BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES

    MDR report key: 2051849 · Received March 15, 2011

    Report

    Report Number
    3015876-2011-00240
    Event Type
    Malfunction
    Date Received
    March 15, 2011
    Date of Event
    February 15, 2011
    Report Date
    February 15, 2011
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K991910
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER DECLINED PHYSIO-CONTROL'S DEVICE REPAIR OFFER. THE DEVICE WAS RETURNED TO THE CUSTOMER IN THE OBSERVED CONDITION AND REMOVED FROM SERVICE. THE CAUSE OF THE REPORTED FAILURE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    DURING A SCHEDULED PREVENTIVE MAINTENANCE INSPECTION, PHYSIO-CONTROL FOUND THAT THE ON/OFF BUTTON INTERMITTENTLY FAILED TO POWER ON THE DEVICE. THERE WAS NO PT USE ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES MKJ PHYSIO-CONTROL, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA