BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BURDICK CARDIOVIVE AT AED

    MDR report key: 1081867 · Received July 21, 2008

    Report

    Report Number
    3014398-2008-00018
    Event Type
    Malfunction
    Date Received
    July 21, 2008
    Date of Event
    June 13, 2008
    Report Date
    July 21, 2008
    Manufacturer
    CARDIAC SCIENCE CORPORATION
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS OF DEVICE INVESTIGATION WILL BE PROVIDED IN FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT DURING AN ATTEMPTED RESCUE THE AED DID NOT FUNCTION PROPERLY. IT DIDN'T RECOGNIZE THE 2ND PAD PLACEMENT AND KEPT STATING "PLACE 2ND PAD ON PATIENT CHEST". THE 911 EMT HAD TO USE THEIR OWN AED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BURDICK CARDIOVIVE AT AED AUTOMATIC EXTERNAL DEFIBRILLATOR MKJ CARDIAC SCIENCE CORPORATION 92532-201 NA

    Patients

    Seq Age Sex Outcome Treatment
    1