BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIRST SAVE

    MDR report key: 219929 · Received April 15, 1999

    Report

    Report Number
    2132572-1999-00008
    Event Type
    Malfunction
    Date Received
    April 15, 1999
    Date of Event
    March 16, 1999
    Report Date
    April 13, 1999
    Manufacturer
    SURVIVALINK CORP.
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE AED WAS BROUGHT TO A RESCUE SCENE. THE STATUS INDICATOR SHOWED THE DEVICE WAS NOT RESCUE READY. THE LID WAS OPENED AND THERE WERE NO LIGHTS OR VOICE PROMPT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FIRST SAVE AUTOMATED EXTERNAL DEFIBRILLATOR (AED) MKJ SURVIVALINK CORP. 9110-001 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other