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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LIFEPAK® 12 DEFIBRILLATOR/MONITOR SERIES; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
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PHYSIO-CONTROL, INC. - 3015876 LIFEPAK® 12 DEFIBRILLATOR/MONITOR SERIES; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) Back to Search Results
Catalog Number 99400-000347
Medical Device Problem Code Unexpected Shutdown (4019)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 01/03/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
(b)(4).Physio-control evaluated the customer¿s device and was unable to duplicate the reported issues.Physio replaced the battery pins as a precaution.Proper device operation was observed through functional and performance testing and the device was returned to the customer for use.
 
Event or Problem Description
The customer contacted physio-control to report that their device powered off by itself.The customer advised physio that they observed the battery reading was incorrectly when the reported issue was observed.There was no patient use associated with the reported event.
 
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Brand Name
LIFEPAK® 12 DEFIBRILLATOR/MONITOR SERIES
Common Device Name
AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
Manufacturer (Section D)
PHYSIO-CONTROL, INC. - 3015876
11811 willows road ne
redmond WA 98052
MDR Report Key8249465
Report Number0003015876-2019-00093
Device Sequence Number13854830
Product Code MKJ
UDI-Device Identifier00721902148217
UDI-Public00721902148217
Combination Product (Y/N)N
Initial Reporter StateAZ
Initial Reporter CountryUS
PMA/510(K) Number
K102972
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) 01/15/2019
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 Catalogue Number99400-000347
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/09/2019
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 01/03/2019
Initial Report FDA Received Date01/15/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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