BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES

    MDR report key: 2251665 · Received August 30, 2011

    Report

    Report Number
    3015876-2011-00643
    Event Type
    Malfunction
    Date Received
    August 30, 2011
    Date of Event
    August 4, 2011
    Report Date
    August 4, 2011
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K973486
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER ADVISED PHYSIO-CONTROL THAT THE DEVICE IS GOING TO BE RETIRED AND REMOVED FROM SERVICE. THE DEVICE WILL NOT BE RETURNED TO PHYSIO-CONTROL FOR FURTHER EVAL. THE CAUSE OF THE REPORTED FAILURE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE DISPLAY INTERMITTENTLY WOULD BLANK OUT AND SHOW ONLY VERTICAL LINES. THERE WERE NO ADVERSE EFFECTS CAUSED TO ANY PT INVOLVED WITH THE REPORTED FAILURE.

    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 UNK