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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
Medical Device Problem Code Failure to Power Up (1476)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 02/02/2021
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
During evaluation, the issue physio-control found the issue (verified).The cause was found to be the ac power adapter.The device passed functional and performance testing and was returned to the customer.
 
Event or Problem Description
During investigation of an unrelated issue, physio-control found that the device would not turn on when the power button was pushed.There was no patient involvement in this event.
 
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Brand Name
LIFEPAK 15 DEFIBRILLATOR/MONITOR
Common Device Name
AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
Manufacturer (Section D)
PHYSIO-CONTROL, INC. - 3015876
11811 willows road ne
redmond WA 98052
MDR Report Key11391264
Report Number0003015876-2021-00487
Device Sequence Number11584832
Product Code MKJ
UDI-Device Identifier00883873871607
UDI-Public00883873871607
Combination Product (Y/N)N
Initial Reporter StateNH
Initial Reporter CountryUS
PMA/510(K) Number
P160026
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source user facility
Initial Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date (Section B) 03/01/2021
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
Operator of Device Health Professional
Device Model Number15
Device Catalogue Number99577-001966
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/04/2021
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 02/06/2021
Initial Report FDA Received Date03/01/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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