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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 Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 08/29/2020
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 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 is freezing.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 Key10590338
Report Number0003015876-2020-01324
Device Sequence Number11457954
Product Code MKJ
UDI-Device Identifier00885074269252
UDI-Public00885074269252
Combination Product (Y/N)N
Initial Reporter StateSC
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 Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 09/25/2020
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 Catalogue Number99400-002505
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/10/2020
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 09/01/2020
Initial Report FDA Received Date09/25/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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