BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIRST SAVE

    MDR report key: 280041 · Received May 26, 2000

    Report

    Report Number
    2132572-2000-00002
    Event Type
    Malfunction
    Date Received
    May 26, 2000
    Date of Event
    April 26, 2000
    Report Date
    May 25, 2000
    Manufacturer
    SURVIVALINK CORP.
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    STATUS INDICATOR SHOWED GREEN BUT WHEN THE LID OF THE "AED" WAS OPENED, NO LED'S CAME ON AND THERE WAS POWER TO THE UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FIRST SAVE AUTOMATED EXTERNAL DEFIBRILLATOR(AED) MKJ SURVIVALINK CORP. 9100-001 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other