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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 99400-002505
Medical Device Problem Code Device Sensing Problem (2917)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 03/10/2020
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Physio-control evaluated the customer's device and was unable to duplicate the reported issue.After observing proper device operation 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 would not recognize defibrillation electrodes.As a result, defibrillation therapy may be unavailable, if needed.There was no report of 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 Key9936381
Report Number0003015876-2020-00483
Device Sequence Number13628492
Product Code MKJ
UDI-Device Identifier00885074269252
UDI-Public00885074269252
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) 04/07/2020
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 Catalogue Number99400-002505
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/10/2020
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 03/10/2020
Initial Report FDA Received Date04/08/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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