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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LIFEPAK® 20 DEFIBRILLATOR/MONITOR AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

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PHYSIO-CONTROL, INC. - 3015876 LIFEPAK® 20 DEFIBRILLATOR/MONITOR AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) Back to Search Results
Model Number 20
Device Problem Device Inoperable (1663)
Patient Problem No Patient Involvement (2645)
Event Date 06/01/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Physio-control performed an initial evaluation of the customer's device and was able to duplicate the reported issue. Physio-control continues to investigate the reported failure and will submit a supplemental report on this event to the fda as provided by 21 cfr 803. 56.
 
Event Description
The customer contacted physio-control to report that when attempting to power on their device, it will not complete the boot-up process. As a result, defibrillation may not be possible, if it were necessary. There was no patient use associated with the reported event.
 
Manufacturer Narrative
Physio-control further evaluated the customer's device and observed that the w18 user interface flex cable had lifted contacts on multiple pins that was causing the device to reset. Physio replaced the w18 user interface flex cable, which resolved the reported issue. After completing other unrelated repairs, proper device operation was observed through functional and performance testing. The device was returned to the customer for use. Physio-control further evaluated the removed w18 user interface flex cable and observed the strain relief of the cable mounted plug connector, designator p21, was observed to be broken and c-2 (+usb) was open which resulted in the device to reboot when the cable was flexed.
 
Event Description
The customer contacted physio-control to report that when attempting to power on their device, it will not complete the boot-up process. As a result, defibrillation may not be possible, if it were necessary. There was no patient use associated with the reported event.
 
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Brand NameLIFEPAK® 20 DEFIBRILLATOR/MONITOR
Type of DeviceAUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
Manufacturer (Section D)
PHYSIO-CONTROL, INC. - 3015876
11811 willows road ne
redmond WA 98052
MDR Report Key7656230
MDR Text Key112995977
Report Number0003015876-2018-01032
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
PMA/PMN Number
K130454
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 10/10/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/02/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number20
Device Catalogue Number99402-000032
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/27/2018
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/13/2018
Is This a Reprocessed and Reused Single-Use Device? No

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