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U.S. Department of Health and Human Services

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

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PHYSIO-CONTROL, INC. - 3015876 LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) Back to Search Results
Model Number 15
Device Problem Device Inoperable (1663)
Patient Problem No Patient Involvement (2645)
Event Date 05/23/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The device was not returned to physio-control for evaluation.A third-party service agent evaluated the device and verified the reported issue.After replacing the system pcb assembly, proper device operation was observed through functional and performance testing.The device was subsequently returned to the customer for use.
 
Event Description
The customer contacted physio-control to report that their device froze during the self test after booting, while checking the device during a daily test.The device illuminated its service led and was only able to power off by removing the batteries.This behaviour is indicative of a lock-up.In this state the device would not be able to charge or shock defibrillation energy, when needed.There was no patient use associated with the reported event.
 
Manufacturer Narrative
Physio-control further evaluated the system pcb assembly, and determined that the cause of the reported issue was due to a failure of the single board computer (sbc).
 
Event Description
The customer contacted physio-control to report that their device froze during the self test after booting, while checking the device during a daily test.The device illuminated its service led and was only able to power off by removing the batteries.This behaviour is indicative of a lock-up.In this state the device would not be able to charge or shock defibrillation energy, when needed.There was no patient use associated with the reported event.
 
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Brand Name
LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR
Type of Device
AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
Manufacturer (Section D)
PHYSIO-CONTROL, INC. - 3015876
11811 willows road ne
redmond WA 98052
MDR Report Key7612664
MDR Text Key111861962
Report Number0003015876-2018-00958
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
PMA/PMN Number
K142430
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign
Type of Report Initial,Followup
Report Date 11/13/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number15
Device Catalogue Number99577-000165
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/03/2018
Initial Date Manufacturer Received 05/23/2018
Initial Date FDA Received06/19/2018
Supplement Dates Manufacturer Received10/19/2018
Supplement Dates FDA Received11/13/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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