BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIRST SAVE

    MDR report key: 222568 · Received May 4, 1999

    Report

    Report Number
    2132572-1999-00033
    Event Type
    Malfunction
    Date Received
    May 4, 1999
    Date of Event
    April 20, 1999
    Report Date
    May 4, 1999
    Manufacturer
    SURVIVALINK CORP.
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    POST MARKET SURVEILLANCE REVIEWED A RESCUE DATA WHERE A SHOCK WAS DELIVERED WHEN RHYTHM WAS NON-SHOCKABLE.

    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