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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 Energy (1211)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 09/10/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
(b)(4).The device was not returned to physio-control for evaluation.The cause of the reported issue could not be determined.Device not evaluated by manufacturer.
 
Event or Problem Description
The customer contacted physio-control to report that they observed an event code logged in the device's memory.The event code logged is related to a potential failure of the device to deliver defibrillation energy.There was no 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 Key9142659
Report Number0003015876-2019-01643
Device Sequence Number3137297
Product Code MKJ
UDI-Device Identifier00883873911549
UDI-Public00883873911549
Combination Product (Y/N)N
Initial Reporter StateIL
Initial Reporter CountryUS
PMA/510(K) Number
K142430
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date (Section B) 10/01/2019
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 Number99577-001264
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 09/10/2019
Initial Report FDA Received Date10/01/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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