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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LIFEPAK® 15 DEFIBRILLATOR/MONITOR AUTOMATED EXTERNAL DEFIBRILLATORS NON-WEARABLE

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PHYSIO-CONTROL, INC. - 3015876 LIFEPAK® 15 DEFIBRILLATOR/MONITOR AUTOMATED EXTERNAL DEFIBRILLATORS NON-WEARABLE Back to Search Results
Model Number 15
Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)
Patient Problem No Patient Involvement (2645)
Event Date 11/19/2019
Event Type  malfunction  
Manufacturer Narrative
Physio-control evaluated the customers device and verified the reported issue. Physio replaced the device's therapy pcb assembly. After completing unrelated repairs, proper device operation was observed through functional and performance testing and the device was returned to the customer for use. Physio-control further evaluated the removed therapy pcb assembly. Physio determined that a transistor, designator q7, on the therapy pcb assembly was the cause of the reported issue.
 
Event Description
While evaluating for a non-critical reported issue, physio-control discovered during troubleshooting of the therapy pcb assembly that a transistor, designator q7, had shorted. The device provided 80% monophasic shock instead of a biphasic energy. In this state, the device may not be able to deliver the correct level of defibrillation energy to a patient if needed. There was no report of patient use associated with the reported event.
 
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Brand NameLIFEPAK® 15 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 Key9470093
MDR Text Key191140609
Report Number0003015876-2019-02001
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P160026
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation
Type of Report Initial
Report Date 12/13/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/13/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number15
Device Catalogue Number99577-001955
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/07/2019
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/19/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/15/2018
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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