BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 20E DEFIBRILLATOR/MONITOR

    MDR report key: 2251673 · Received August 31, 2011

    Report

    Report Number
    3015876-2011-00645
    Event Type
    Malfunction
    Date Received
    August 31, 2011
    Date of Event
    August 1, 2011
    Report Date
    August 1, 2011
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K073089
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL EVALUATED THE DEVICE AND FOUND THE THERAPY PCB AND METAL SHIELD UNDERNEATH DAMAGED. PHYSIO WILL REPLACE THE THERAPY PCB AND METAL SHIELD. PHYSIO IS IN THE PROCESS OF REPAIRING THE DEVICE AND CONTINUES TO INVESTIGATE THE REPORTED EVENT AND WILL SUBMIT A SUPPLEMENTAL REPORT ON THIS EVENT TO THE FDA AS PROVIDED BY 21 CFR 803 56.

    Description of Event or Problem · 1

    DURING A USER TEST, IT WAS REPORTED THAT THERE WAS A POPPING SOUND AND THE DEVICE HAD NO DEFIBRILLATION OUTPUT THEREAFTER. THERE WAS NO PT USE ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEPAK 20E DEFIBRILLATOR/MONITOR MKJ PHYSIO-CONTROL, INC. 20E NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA