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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 Deliver Shock/Stimulation (1133)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 11/17/2020
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Physio-control evaluated the customer's device and was unable to duplicate the reported issue.After completing other unrelated repairs, proper device operation was observed through functional and performance testing.The device was returned to the customer for use.The cause of the reported issue could not be determined.
 
Event or Problem Description
The customer contacted physio-control to report that their device unexpectedly dumped a shock and then would not shock.As a result, defibrillation therapy may have been unavailable, if needed.There was no report of patient use associated with the reported 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 Key10969293
Report Number0003015876-2020-01826
Device Sequence Number16688824
Product Code MKJ
UDI-Device Identifier00883873884348
UDI-Public00883873884348
Combination Product (Y/N)N
Initial Reporter CountryCA
PMA/510(K) Number
K142430
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source foreign
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 12/08/2020
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 Number99577-001372
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/17/2020
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 11/17/2020
Initial Report FDA Received Date12/08/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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