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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 Power Problem (3010)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 12/19/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Physio-control evaluated the customer's device and verified the reported issue.The customer's device was scrapped and the customer was provided with a replacement device.The root cause of the issue was due to the single board computer.
 
Event or Problem Description
The customer contacted physio-control to report a non-critical issue with their device.There was no report of patient use associated with the reported event.Upon evaluation of the customer's device, physio-control observed that the device failed to boot up.
 
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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 Key9878355
Report Number0003015876-2020-00416
Device Sequence Number2909860
Product Code MKJ
UDI-Device Identifier00883873979358
UDI-Public00883873979358
Combination Product (Y/N)N
Initial Reporter StateCA
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 Other
Type of Report Initial
Report Date (Section B) 03/25/2020
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 Number99577-000061
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/30/2020
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 03/05/2020
Initial Report FDA Received Date03/25/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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