BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR

    MDR report key: 3043488 · Received April 9, 2013

    Report

    Report Number
    3015876-2013-00282
    Event Type
    Malfunction
    Date Received
    April 9, 2013
    Date of Event
    February 18, 2013
    Report Date
    March 14, 2013
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    LDD
    PMA / PMN Number
    K063119
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL REPLACED THE THERAPY PCB ASSEMBLY AND CONFIRMED PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS REPAIRED AND RETURNED TO THE CUSTOMER FOR USE. FURTHER EVALUATION OF THE REMOVED THERAPY PCB ASSEMBLY DETERMINED THE CAUSE FOR THE MALFUNCTION TO BE A TEMPERATURE SENSITIVE DEFECTIVE IC CHIP, DESIGNATOR U24.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE FAILED THE 3 AM SELF-TEST AND THERE WERE SEVERAL EVENT CODES LOGGED IN THE MEMORY. PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. PHYSIO-CONTROL REPLACED THE THERAPY PCB ASSEMBLY TO REPAIR THE DEVICE. FURTHER ANALYSIS OF THE REMOVED THERAPY PCB ASSEMBLY AT THE FAILURE ANALYSIS CENTER FOUND A MALFUNCTION THAT PREVENTED DEFIBRILLATION THERAPY DELIVERY. WHILE CHARGING DEFIBRILLATION ENERGY, THE DEVICE WOULD SLOWLY CHARGE AND LOSE POWER. THERE WAS NO PATIENT USE ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146148 LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR DC-DEFIBRILLATOR, LOW-ENERGY, (INCLUDING PADDLES) LDD PHYSIO-CONTROL, INC 20

    Patients

    Seq Age Sex Outcome Treatment
    1