BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIRST SAVE

    MDR report key: 294718 · Received September 5, 2000

    Report

    Report Number
    2132572-2000-00003
    Event Type
    Malfunction
    Date Received
    September 5, 2000
    Date of Event
    August 14, 2000
    Manufacturer
    SURVIVALINK CORP.
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    CUSTOMER FELT AN ELECTRIC SHOCK WHEN CHANGING ELECTRODES.

    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