BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES

    MDR report key: 1890539 · Received October 29, 2010

    Report

    Report Number
    3015876-2010-01205
    Event Type
    Malfunction
    Date Received
    October 29, 2010
    Date of Event
    September 29, 2010
    Report Date
    September 29, 2010
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K991910
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): PHYSIO-CONTROL'S INITIAL DEVICE EVAL WAS UNABLE TO DUPLICATE THE REPORTED FAILURE. THE CUSTOMER DECLINED PHYSIO'S ADD'L DEVICE EVAL/REPAIR AND OPTED TO SCRAP THE DEVICE. A CONCLUSIVE CAUSE FOR THE REPORTED PROBLEM COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE LOST POWER DURING A PT TRANSPORT. THERE WAS NO FURTHER DETAILS ON THE EVENT AND/OR THE PT PROVIDED, AND NO ADVERSE EVENT REPORTED AS THE RESULT OF THE DEVICE USE.

    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