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dennis100
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« on: January 28, 2017, 03:21:57 AM »

Model Number MODEL 250
Event Date 01/01/2010
Event Type Malfunction
Event Description
It was reported that the handheld's ac adapter cable had a defect causing the handheld to not charge. Troubleshooting was performed, but the problem persisted. Product was returned to the manufacturer, but analysis is pending.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1948993
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dennis100
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« Reply #1 on: January 28, 2017, 03:23:10 AM »

Model Number MODEL 250
Event Date 12/01/2010
Event Type Malfunction
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to death or serious injury.

Event Description
It was reported that the manufacturer representative's handheld battery was not charging and that the ac adapter cord had to be held in a specific position for the device to charge. The handheld computer, software flashcard, and the ac adapter cord are en route to the manufacturer headquarters where analysis will be performed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1984755
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dennis100
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« Reply #2 on: January 28, 2017, 03:24:15 AM »

Model Number MODEL 250
Event Date 01/01/2010
Event Type Malfunction
Event Description
It was reported that the physician's hand held was charging intermittently and it is suspected that the ac adapter cord is not working properly. The physician requested a new hand held to replace the non-working device. Good faith attempts to obtain the non-working device. Good faith attempts to obtain the non-working device for analysis have been made, but the device has not been returned to date.

Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1621078
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dennis100
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« Reply #3 on: January 28, 2017, 03:25:20 AM »

Model Number 250
Event Date 02/01/2010
Event Type Malfunction
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to death or serious injury.

Event Description
It was reported that the physician's hand held was not charging properly with the ac adapter cable. The physician used another working ac adapter cable and the hand held was able to be charged with no further problems. Good faith attempts to obtain power cord (ac adapter cable) for analysis have been made, but the cord has not been returned to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1639311
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dennis100
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« Reply #4 on: January 28, 2017, 03:26:55 AM »

Model Number MODEL 250
Event Date 06/01/2010
Event Type Malfunction
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a serious injury or death.

Event Description
It was reported to manufacturer that the distributor in (b) (4) found a bad electrical contact of the cable that connected the ac adapter with the handheld computer. The product has not been returned to manufacturer for analysis. Good faith attempts to obtain additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1773954
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dennis100
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« Reply #5 on: January 28, 2017, 03:27:52 AM »

Model Number 250
Event Date 06/21/2010
Event Type Malfunction
Event Description
It was reported that the physician's hp hand held would not hold a charge any longer. This event began recently, and it was noted that the product is stored in the office and is always plugged in while not in use. The physician requested a new hand held to replace the non-working device. The hand held and software flashcard were returned to manufacturer for analysis where there were no anomalies found and both the software and hand held performed according to specifications; however, the ac adapter was not returned for analysis and therefore, the ac adapter is not able to be ruled out as the cause of the issue the site was experiencing. Good faith attempts are underway to obtain the ac adapter cable from the site for analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1786065
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dennis100
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« Reply #6 on: January 28, 2017, 03:29:19 AM »

Model Number 250
Event Date 04/01/2010
Event Type Malfunction
Event Description
It was reported that the site's charging cradle was broken. Troubleshooting was performed where the ac adapter cable was moved from the back of the cradle, and plugged into the flying lead on the serial cable. This configuration was plugged directly into the hand held rather than using the charging cradle. It was observed that touching or moving the connection caused intermittent charging. The site was sent a new cable to replace the non-working cable. The non-working cable has been retrieved, is en route to mfr for analysis.

Manufacturer Narrative
Device failure is suspected, but did not cause or contributed to death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1706682
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dennis100
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« Reply #7 on: January 28, 2017, 03:30:34 AM »

Model Number MODEL 250
Event Date 01/01/2010
Event Type Malfunction
Event Description
It was reported that the physician's hand held was charging intermittently and it is suspected that the ac adapter cord is not working properly. The physician requested a new hand held to replace the non-working device. Good faith attempts to obtain the non-working device. Good faith attempts to obtain the non-working device for analysis have been made, but the device has not been returned to date.

Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1621078
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dennis100
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« Reply #8 on: January 28, 2017, 03:31:35 AM »

Model Number MODEL 250
Event Date 04/01/2010
Event Type Malfunction
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

Event Description
Reporter indicated a vns (b)(6) handheld computer was not holding a charge due to the a/c adapter having a loose connection. The computer has been requested for return, but has not been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1720392
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dennis100
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« Reply #9 on: January 28, 2017, 03:32:35 AM »

Model Number MODEL 250
Event Date 06/15/2010
Event Type Malfunction
Event Description
Initial reporter indicated that their (b) (6) handheld computer is not turning on. It was reported that it had been plugged in overnight and the power light was green while plugged in. When the handheld was unplugged, the light turned orange. It was plugged back in and the light stayed orange. The handheld was returned for product analysis without the ac adapter and serial cable. Testing on the handheld showed it met specifications. At this time, the issue is believed to be with the ac adapter. Good faith attempts thus far have been unsuccessful in attaining that for product analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1760912
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dennis100
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« Reply #10 on: January 28, 2017, 12:00:27 PM »

Model Number 250
Device Problems Break; Failure to charge
Event Date 10/06/2009
Event Type Malfunction
Event Description
It was reported that the sites handheld was broken and that the connector piece in the handheld where the ac adapter is inserted had broken. The handheld would subsequently not charge as a result of the broken connector piece. The handheld, ac adapter, serial cable, db9 adapter, and (b) (4) software flashcard were returned to mfr for analysis. Analysis identified that the connector of the hand held device was damaged and the ac adapter could no longer charge the main battery. The cause of the damage ac adapter is unk, however, it is most likely associated with mishandling of the device. No other anomalies on the device performance were noted during testing using a known good ac adapter or the main battery with a full charge.

Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1542373
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dennis100
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« Reply #11 on: January 29, 2017, 02:55:08 AM »

Model Number MODEL 250
Event Date 08/20/2009
Event Type Malfunction
Manufacturer Narrative
Device malfunction is suspected, but did not cause or contribute to a death or serious injury.

Event Description
Reporter indicated a vns therapy programming handheld ac adapter cord was not working. The handheld had been plugged in for several hours and would not charge or turn on. When the handheld was plugged in with a separate power cord, the handheld power light illuminated, charged and turned on as intended. Good faith attempts to obtain device have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1502863
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dennis100
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« Reply #12 on: January 30, 2017, 01:59:54 AM »

Model Number 250
Event Date 05/04/2009
Event Type Malfunction
Event Description
It was reported to manufacturer that the sites hp hand held ac adapter cord had broken and as a result, they were no longer able to charge the hand held. The site requested a new hand held be sent to replace that non-working device. It is unk how the ac adapter cord broke, but it was reported that "a black piece on the cord broke and fell off". Good faith attempts to obtain the non-working device for analysis have been made, but have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1436502
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dennis100
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« Reply #13 on: January 30, 2017, 02:00:55 AM »

Model Number 250
Event Date 01/01/2009
Event Type Malfunction
Event Description
Rptr indicated they were having issues with their handheld computer. The device was sent to the manufacturer for analysis. Before analysis was completed info was found that the issue had previously been resolved with troubleshooting. Product analysis was later completed and found that the flashcard was missing a specific file that is meant to be installed on the handheld computer. Product analysis also found that the ac power adapter used to charge the handheld computer was damaged and unable to charge the device. When a known good ac power adapter was used, no other anomalies were identified with the handheld computer.

Manufacturer Narrative
Device failure occurred but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1375769
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dennis100
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« Reply #14 on: January 30, 2017, 08:21:13 AM »

Model Number MODEL 250
Event Date 10/01/2008
Event Type Malfunction
Event Description
It was reported that a handheld computer's power adapter cord was physically broken. It will only charge the handheld when held a certain way. A replacement handheld computer was sent to the physician. Good faith attempts to obtain the old handheld for analysis have been unsuccessful to date.

Manufacturer Narrative
Device malfunction is suspected, but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1237727
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dennis100
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« Reply #15 on: January 31, 2017, 01:54:12 AM »

Model Number 250
Event Date 08/01/2008
Event Type Malfunction
Event Description
Reporter indicated that the gold prongs on the ac adapter cord for his hp jornada handheld computer were broken. Product has been requested, but has not been returned to manufacture to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1172597
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dennis100
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« Reply #16 on: January 31, 2017, 01:54:56 AM »

Model Number 250
Event Date 07/14/2008
Event Type Malfunction
Event Description
Initial reporter indicated that they were at a physicians office testing out their new programming system and "she couldn't get the dell x50 handheld computer turn on event when plugged into the wall". When plugged into the wall, the power light did not light up and the lock button was not in the red position. A hard reset and soft reset was performed and the handheld did not turn on. The handheld was returned for analysis with 7. 1 programming software. Both products went through product analysis and no anomalies were identified against the handheld or software performance. The handheld was returned without the ac adapter therefore a malfunction is suspected against the ac adapter. Good faith attempts have been made for product return.

Manufacturer Narrative
Device malfunction suspected, but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1148007
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dennis100
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« Reply #17 on: January 31, 2017, 01:56:25 AM »

Model Number 250
Event Date 06/01/2008
Event Type Malfunction
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to death or serious injury.

Event Description
It was reported to mfr that their ac adapter cable for the hand held was frayed and requested that a new one be sent to the site. The non-working cable has been sent back to mfr and analysis is underway.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1081558
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dennis100
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« Reply #18 on: February 01, 2017, 07:50:13 AM »

Model Number 250
Event Date 04/30/2008
Event Type Malfunction
Manufacturer Narrative
Device malfunction suspected, but did not cause or contribute to a death or serious injury.

Event Description
Initial reporter indicated that a hospital needed a new power cord for their hp jonada handheld computer, because it was not "holding its charge". Reported "the gold prongs were facing up, and they tried using different outlets. The physician thinks the problem is the ac adapter cord because it is loose. " good faith attempts have been made for product return.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1053320
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dennis100
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« Reply #19 on: February 01, 2017, 07:51:09 AM »

Model Number 250
Event Date 03/01/2008
Event Type Malfunction
Event Description
It was reported to mfr that a black piece of plastic that covered the prongs on the ac adapter cable had broken off, which made the hand held incapable of being plugged in to charge. A new cable was sent to the site and the hand held is now able to be charged with no add'l problems. Attempts to obtain the damaged cable have been made, but have been unsuccessful to date.

Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1031298
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dennis100
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« Reply #20 on: February 03, 2017, 02:22:21 AM »

Model Number MODEL 250
Event Date 10/01/2007
Event Type Malfunction
Manufacturer Narrative
Device malfunction occurred, but did not cause or contribute to a death or serious injury.

Event Description
Reporter indicated the ac adapter that connects to the handheld programming system is sometimes loose due to normal wear and tear. The product was returned to the mfr and a product analysis was performed. Visual inspection identified a broken solder joint between the pcb and a screw mount. The screw mount connects the back of the handheld to the pcb near the main battery connector allowing good electrical contact between the main battery and the handheld device. This anomaly can cause the intermittent issues associated with loss of power while operating the device on battery power. It can also prevent the main battery from being charged using the ac adapter.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=976450
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dennis100
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« Reply #21 on: February 03, 2017, 02:23:12 AM »

Model Number MODEL 250
Event Date 09/01/2007
Event Type Malfunction
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.

Event Description
Reporter indicated that an hp handheld computer's ac adapter was broken. The connection which inserts into the handheld computer was reported to have been broken completely off. The ac adapter was reported to have been stuck behind a cabinet and could not be returned for analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=922854
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dennis100
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« Reply #22 on: February 04, 2017, 03:25:41 AM »

Model Number MODEL 250
Event Date 06/01/2005
Event Type Malfunction
Manufacturer Narrative
Device malfunction occurred, but did not cause or contribute to a death or serious injury.

Event Description
Reporter indicated that his vns therapy programming handheld was not operating properly. He stated that "the power cord is broken and the handheld has horizontal lines going across it. " troubleshooting did not resolve the issue. The handheld was subsequently returned to manufacturer for product analysis. The reported complaint associated with the power cord was verified during visual analysis. External visual inspection found that the plug on the ac adapter that attaches to the handheld was broken, and consequently the ac adapter was no longer able to plug into the handheld to charge the main battery. The reported complaint associated with horizontal lines on the screen was also verified. The cause for the lines is associated with loss of power to the handheld device during operation. The horizontal lines on the screen mostly likely appeared as a result of the screen loosing power as the device shut down abruptly. This is expected behavior when the main battery is depleted while the device is in operation.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=900976
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dennis100
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« Reply #23 on: February 04, 2017, 03:26:30 AM »

Model Number MODEL 250
Event Date 09/01/2006
Event Type Malfunction
Manufacturer Narrative
Device malfunction occurred, but did not cause or contribute to a death or serious injury.

Event Description
Reporter indicated that his vns therapy programming handheld was no longer properly holding a charge. Handheld was subsequently returned to manufacturer for product analysis. An analysis was performed on the handheld and the cause for the complaint was found to be associated with a broken ac adapter. Visual inspection identified that the connector to the hand held device was damaged, and the ac adapter could no longer charge the main battery. No other anomalies on the device performance were noted during testing using a known good ac adapter or the main battery with a full charge.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=902457
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dennis100
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« Reply #24 on: February 04, 2017, 03:27:23 AM »

Model Number MODEL 250
Event Date 05/01/2006
Event Type Malfunction
Event Description
Reporter indicated that his vns therapy programming handheld power cord was broken. Handheld and power cord were subsequently returned to manufacturer for product analysis. An analysis was performed on both products and the broken power cord was verified during the visual analysis. It was found that the ac adapter connector to the handheld was broken, and no longer able to provide power to the handheld. No other anomalies with device performance were noted during testing using a known good ac adapter or the main battery with a full charge.

Manufacturer Narrative
Device malfunction occurred, but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=902196
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dennis100
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« Reply #25 on: February 04, 2017, 03:28:11 AM »

Model Number MODEL 250
Event Type Malfunction
Event Description
Reporter indicated that her vns therapy programming handheld was not operating properly, in that "it was continually locking up and resetting when it was being used. " it was additionally reported that the handheld power cord was broken. Handheld and power cord were subsequently returned to manufacturer for product analysis. An analysis was performed on the handheld and the cause for the first complaint was found to be associated with a broken solder connection near the main battery terminal. The broken solder connection prevented the main battery from making good electrical contact with the pcb. This condition caused the handheld to intermittently lose power and shut down while operating. During the analysis, visual inspection also verified the complaint that the power cord was broken off, and part of it was still in the connector port. As a result the ac adapter could not longer charge the main battery. The damaged power cord is most likely associated with mishandling of the handheld device.

Manufacturer Narrative
Device malfunction occurred, but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=902407
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dennis100
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« Reply #26 on: February 04, 2017, 03:28:57 AM »

Model Number MODEL 250
Event Date 01/01/2007
Event Type Malfunction
Manufacturer Narrative
Device malfunction occurred, but did not cause or contribute to a death or serious injury.

Event Description
Reporter indicated that his vns therapy programming handheld power cord was broken. Cord was subsequently returned to manufacturer for analysis. An analysis was performed on the ac adapter and the reported complaint was verified. Visual inspection identified that the connector to the handheld device was damaged, and the ac adapter could no longer charge the handheld main battery.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=902424
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dennis100
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« Reply #27 on: February 04, 2017, 03:29:45 AM »

Model Number MODEL 250
Event Date 11/01/2006
Event Type Malfunction
Manufacturer Narrative
Device malfunction occurred, but did not cause or contribute to a death or serious injury.

Event Description
Reporter indicated that her vns therapy programming handheld would not properly power on, even after charging it overnight. Handheld was subsequently returned to mfr for product analysis. An analysis was performed on the handheld and the cause for the complaint was found to be associated with a broken ac adapter. Visual inspection identified that the connector to the handheld device was damaged, and the ac adapter could not longer charge the main battery. No other anomalies on the device performance were noted during testing using a known good ac adapter or the main battery with a full charge.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=902436
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« Reply #28 on: February 04, 2017, 03:30:33 AM »

Model Number MODEL 250
Event Date 05/01/2006
Event Type Malfunction
Event Description
Reporter indicated that her vns therapy programming handheld was no longer charging correctly. The handheld and accompanying charger were subsequently returned to manufacturer for product analysis. An analysis was performed on the products and the cause for the battery performance issue was found to be associated with a broken ac adapter. Visual inspection identified that the connector to the handheld device was damaged, and the ac adapter could no longer charge the main battery. No other anomalies on the device performance were noted during testing using a known good ac adapter or the main battery with a full charge.

Manufacturer Narrative
Device malfunction occurred, but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=902195
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« Reply #29 on: February 04, 2017, 03:31:20 AM »

Model Number MODEL 250
Event Date 07/01/2007
Event Type Malfunction
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

Event Description
It was reported that a site's handheld ac adapter shorted out when it was plugged into an electrical outlet. A replacement ac adapter was sent. Attempts to have original ac adapter returned have been unsuccessful.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=897927
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