BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR

    MDR report key: 1010100 · Received March 10, 2008

    Report

    Report Number
    3015876-2008-00157
    Event Type
    Malfunction
    Date Received
    March 10, 2008
    Date of Event
    February 11, 2008
    Report Date
    February 11, 2008
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K955854
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER DECLINED AN OFFER OF SERVICE BECAUSE THE WARRANTY HAD EXPIRED, AND THEY WILL BE PURCHASING A NEW DEFIBRILLATOR.

    Description of Event or Problem · 1

    FOUND DURING INSPECTION REPORTEDLY, THE DEVICE DISPLAYED A SERVICE WRENCH ICON AND THEN, LATER, WOULD NOT POWER UP. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR MKJ PHYSIO-CONTROL, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA