BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARDIAC SCIENCE

    MDR report key: 2132759 · Received June 10, 2011

    Report

    Report Number
    2132759
    Event Type
    Injury
    Date Received
    June 10, 2011
    Date of Event
    June 6, 2011
    Report Date
    June 8, 2011
    Product Code
    LDD
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING PATIENT CODE SITUATION AED AND PADS WERE APPLIED BY EMT HEALTH CARE PROFESSIONALS. AED CONTINUED TO READ "PLACE ELECTRODES ON PATIENT'S BARE CHEST", AND DID NOT ANALYZE. KEPT REPEATING "PLACE ELECTRODES ON PATIENT'S BARE CHEST". IT WAS NOTED POST EVENT THAT THE BLUE PROTECTIVE LINER WAS NOT REMOVED FROM INSIDE OF THE PADS. SUBSEQUENTLY EMS TEAM PLACED ALTERNATE AED DEVICE FOR EVALUATION. ELECTRODES HAVE BEEN SAVED, HOWEVER, THE MODEL NUMBER IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARDIAC SCIENCE DEFIBRILLATION ELECTRODES LDD NOT AVAILABLE NOT AVAILABLE

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization