BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIRST SAVE

    MDR report key: 448615 · Received March 13, 2003

    Report

    Report Number
    2132572-2003-00003
    Event Type
    Malfunction
    Date Received
    March 13, 2003
    Date of Event
    December 22, 2002
    Report Date
    March 11, 2003
    Manufacturer
    SURVIVALINK CORP.
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE AED SHOCKED DURING A COMPLEX ECG PATTERN THAT CONTRIBUTED TO THE ALGORITHM TO "DOUBLE COUNT" BEATS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FIRST SAVE AUTOMATED EXTERNAL DEFIBRILLATOR (AED) MKJ SURVIVALINK CORP. 9210 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other