BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR

    MDR report key: 960932 · Received December 4, 2007

    Report

    Report Number
    3015876-2007-00556
    Event Type
    Injury
    Date Received
    December 4, 2007
    Report Date
    November 16, 2007
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K983393
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL, INC. EVALUATED THE DEVICE. THE ROOT CAUSE WAS DETERMINED TO BE DUE TO A ERROR CODE. AFTER CLEARING THE ERROR CODE, PROPER OPERATION WAS CONFIRMED AND THE DEVICE WAS RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE DISPLAYED THE WRENCH ICON. NO PATIENT USE WAS 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 YR