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U.S. Department of Health and Human Services

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

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PHYSIO-CONTROL, INC. - 3015876 LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) Back to Search Results
Model Number 20
Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)
Patient Problem No Patient Involvement (2645)
Event Date 09/08/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Device was not returned to physio control. The third-party service agent evaluated customer's device and verified the reported issue. After replacing the therapy pcb assembly and performing some unrelated repairs proper device operation was observed through functional and performance testing. The device was subsequently returned to customer for use.
 
Event Description
A customer contacted physio-control to report that their device had illuminated its service led and had logged an event code in its memory that is indicative of a device failure which could result in a partial loss of defibrillator output energy due to a loss of the negative portion of the biphasic output waveform. The defibrillator output energy could be reduced by up to approximately 20% from the selected energy level. There was no patient use associated with the reported event.
 
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Brand NameLIFEPAK(R) 20 DEFIBRILLATOR/MONITOR
Type of DeviceAUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
Manufacturer (Section D)
PHYSIO-CONTROL, INC. - 3015876
11811 willows road ne
redmond WA 98052
Manufacturer (Section G)
PHYSIO-CONTROL, INC. - 3015876
11811 willows road ne
redmond WA 98052
Manufacturer Contact
todd bandy
11811 willows road ne
redmond, WA 98052
4258674000
MDR Report Key9098111
MDR Text Key159694378
Report Number0003015876-2019-01569
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
Reporter Country CodeES
PMA/PMN Number
K130454
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup,Followup
Report Date 04/02/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/20/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number20
Device Catalogue Number99402-000071
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/10/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/02/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/01/2010
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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