BEUDAMED
    FDA Adverse Event Other Summary report: N

    HEARTSTART

    MDR report key: 671683 · Received February 6, 2006

    Report

    Report Number
    9610483-2006-00023
    Event Type
    Other
    Date Received
    February 6, 2006
    Date of Event
    May 19, 2001
    Report Date
    May 21, 2001
    Manufacturer
    LAERDAL MEDICAL A.S.
    Product Code
    MKJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING AN INCIDENT IN 2001 INVOLVING A MALE PATIENT WHO HAD BEEN IN A CAR ACCIDANT AND WAS CONSCIOUS AND AWAKE, THIS DEFIBRILLATOR BEING USED TO MONITOR THE PATIENT WITH MOORE MEDICAL MONITORING PADS, COULD NOT GET PAST THE INITIAL "CHECK ELECTRODES" PROMPT AND SHUT DOWN AT 2 MM. ON THE SAME DAY THE CUSTOMER HAD A SECOND INCIDENT INVOLVING FEMALE PATIENT WHOHAD PASSED OUT FROM HEAT EXHAUSTION AND WAS AWAKE WHEN THE CREW ARRIVED. THIS SAME DEFIBRILLATOR WAS BEING USED TO MONITOR THE PATIENT WITH MOORE MEDICAL MONITORING PADS AND AGAIN IT NEVER GOT PAST THE "CHECK ELECTRODES" PROMPT AND SHUT DOWN IN 2MM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTSTART SAED MKJ LAERDAL MEDICAL A.S. HS3000QR 9607

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Other