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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 07/31/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The device was not returned to physio-control.A third-party service agent performed an initial evaluation of the customer's device and verified the reported issue.Physio-control continues to investigate the reported issue and will submit a supplemental report on this event to the fda as provided by 21 cfr 803.56.Device not evaluated by manufacturer.
 
Event Description
A third-party service agent contacted physio-control to report that their customer's device had failed its daily user test.Upon initial evaluation, by the service agent, it was observed that the device 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.
 
Manufacturer Narrative
The third-party service agent replaced the therapy pcb assembly and proper device operation was observed through functional and performance testing.The device was subsequently returned to the customer for use.The replaced therapy pcb assembly was further evaluated by physio-control failure analysis center and determined that the cause of the reported issue was due to shorted pins 5 to 9 on diode, designator cr30.
 
Event Description
A third-party service agent contacted physio-control to report that their customer's device had failed its daily user test.Upon initial evaluation, by the service agent, it was observed that the device 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 Name
LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR
Type of Device
AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
Manufacturer (Section D)
PHYSIO-CONTROL, INC. - 3015876
11811 willows road ne
redmond WA 98052
MDR Report Key9076156
MDR Text Key158815685
Report Number0003015876-2019-01545
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 foreign
Type of Report Initial,Followup
Report Date 02/07/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/17/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number20
Device Catalogue Number99402-000019
Was Device Available for Evaluation? Yes
Date Manufacturer Received01/15/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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