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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 Unexpected Shutdown (4019)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 11/21/2020
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Physio-control evaluated the customer's device and verified the reported issue.Physio replaced the battery contact fin pcb to resolve the reported issue.After observing proper device operation through functional and performance testing, the device was returned to the customer for use.
 
Event or Problem Description
The customer contacted physio-control to report that their device unexpectedly shut down.There was no patient use reported with the 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 Key10998608
Report Number0003015876-2020-01868
Device Sequence Number3823572
Product Code MKJ
UDI-Device Identifier00883873988114
UDI-Public00883873988114
Combination Product (Y/N)N
Initial Reporter StateFL
Initial Reporter CountryUS
PMA/510(K) Number
K142430
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source user facility
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 12/11/2020
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 Number99577-000037
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/30/2020
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 11/23/2020
Initial Report FDA Received Date12/13/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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