BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 1000 DEFIBRILLATOR

    MDR report key: 1983314 · Received February 3, 2011

    Report

    Report Number
    3015876-2011-00104
    Event Type
    Malfunction
    Date Received
    February 3, 2011
    Date of Event
    January 5, 2011
    Report Date
    January 5, 2011
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K042404
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): PHYSIO-CONTROL FURTHER EVALUATED THE DEVICE AT THE FAILURE ANALYSIS CENTER AND VERIFIED THE REPORTED FAILURE TO CHARGE ENERGY. THE CAUSE OF THE MALFUNCTION WAS DETERMINED TO BE A FAILURE OF THE HIGH ENERGY STORAGE CAPACITOR, PIN ONE HAD AN INTERMITTENT CONNECTION WITH THE J502 PCB MOUNTED JACK CONNECTOR. A REPLACEMENT DEVICE WAS PROVIDED TO THE CUSTOMER.

    Description of Event or Problem · 1

    DURING AN INSPECTION, PHYSIO-CONTROL FOUND THAT THE DEVICE WAS UNABLE TO CHARGE DEFIBRILLATION ENERGY. THERE WAS NO PATIENT USE ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEPAK 1000 DEFIBRILLATOR MKJ PHYSIO-CONTROL, INC 1000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA