BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 20E DEFIBRILLATOR/MONITOR

    MDR report key: 3770867 · Received April 24, 2014

    Report

    Report Number
    3015876-2014-00461
    Event Type
    Malfunction
    Date Received
    April 24, 2014
    Date of Event
    March 29, 2014
    Report Date
    March 31, 2014
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K073089
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL EVALUATED THE DEVICE AND CONFIRMED THE REPORTED ISSUE. THE CAUSE OF THE REPORTED ISSUE WAS DETERMINED TO BE DUE TO A FAILURE OF DIODE CR30 ON THE THERAPY PCB ASSEMBLY. THE DIODE WAS SHORTED FROM PINS 5 TO 9. THE DEVICE WAS REPAIRED BY REPLACING THE THERAPY PCB ASSEMBLY. FOLLOWING THE REPAIR, PROPER OPERATION WAS CONFIRMED DURING FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS SUBSEQUENTLY RETURNED TO THE CUSTOMER FOR USE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE WAS DISPLAYING THE SERVICE INDICATOR. UPON EVALUATION, PHYSIO-CONTROL OBSERVED THAT DEVICE HAD LOGGED EVENT CODE 9C19. THE EVENT CODE IS INDICATIVE OF A DEVICE FAILURE THAT COULD RESULT IN A PARTIAL LOSS OF DEFIBRILLATOR OUTPUT ENERGY DUE TO A LOSS OF THE NEGATIVE PORTION OF THE BIPHASIC OUTPUT WAVEFORM. THE DEFIBRILLATOR OUTPUT ENERGY COULD BE REDUCED BY UP TO APPROXIMATELY 20% FROM THE SELECTED ENERGY LEVEL. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED WITH THE REPORTED ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248948 LIFEPAK(R) 20E DEFIBRILLATOR/MONITOR DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC 20E

    Patients

    Seq Age Sex Outcome Treatment
    1