BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 1000 DEFIBRILLATOR

    MDR report key: 1903215 · Received November 12, 2010

    Report

    Report Number
    3015876-2010-01247
    Event Type
    Malfunction
    Date Received
    November 12, 2010
    Date of Event
    October 15, 2010
    Report Date
    October 15, 2010
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K042404
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. PHYSIO DETERMINED THE CAUSE OF THE FAILURE TO BE A FAILED INDUCTOR, DESIGNATOR, L1, FROM THE ANALOG PCB ASSEMBLY. A REPLACEMENT DEVICE WAS PROVIDED TO THE CUSTOMER.

    Description of Event or Problem · 1

    DURING A ROUTINE INSPECTION, THE DEVICE WAS FOUND TO DISPLAY THE WRENCH AND BATTERY ICONS AND FAILED TO POWER ON. 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