BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 20EDEFIBRILLATOR/MONITOR

    MDR report key: 3181387 · Received June 21, 2013

    Report

    Report Number
    3015876-2013-00534
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    May 31, 2013
    Report Date
    May 31, 2013
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K073089
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    SERVICE PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL FURTHER EVALUATED THE CAPACITOR, THERAPY PCB ASSEMBLY, USER INTERFACE PCB ASSEMBLY AND SYSTEM CONTROLLER PCB ASSEMBLY. PHYSIO-CONTROL DETERMINED THAT THE CAUSE OF THE REPORTED FAILURE WAS DUE TO A DIODE, DESIGNATOR CR44, ON THE THERAPY PCB BEING SHORTED. THIS DIODE BEING SHORTED CAUSED SMOKE AND EXCESSIVE DAMAGE DUE TO EXCESSIVE CURRENT.

    Additional Manufacturer Narrative · 1

    (B)(4): PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. PHYSIO-CONTROL THEN REPLACED THE CAPACITOR, THERAPY PCB ASSEMBLY, USER INTERFACE PCB ASSEMBLY AND SYSTEM CONTROLLER PCB ASSEMBLY. PROPER DEVICE OPERATION WAS OBSERVED THROUGH FUNCTIONAL AND PERFORMANCE TESTING. AFTER REPAIR THE DEVICE WAS RETURNED TO THE CUSTOMER FOR USE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO A PHYSIO-CONTROL SERVICE REPRESENTATIVE THAT THE SERVICE INDICATOR ON THE CUSTOMER'S DEVICE WAS ILLUMINATED. PHYSIO-CONTROL EVALUATED THE DEVICE BUT COULD NOT VERIFY THE REPORTED FAILURE. WHEN THE DEVICE WAS TURNED ON, THE SERVICE INDICATOR WAS NOT ILLUMINATED. DURING THE MECHANICAL AND PERFORMANCE TESTING OF THE DEVICE, A LOUD BANG AND A BRIGHT FLASH CAME FROM THE DEVICE. FOLLOWING A MANUAL DISCHARGE OF THE DEVICE'S CAPACITOR, A SECOND FLASH AND BANG WERE OBSERVED. THE DEVICE WAS THEN NO LONGER USABLE.THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283233 LIFEPAK(R) 20EDEFIBRILLATOR/MONITOR DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC 20E

    Patients

    Seq Age Sex Outcome Treatment
    1