BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART 2000

    MDR report key: 283320 · Received June 22, 2000

    Report

    Report Number
    MW1019176
    Event Type
    Malfunction
    Date Received
    June 22, 2000
    Date of Event
    June 17, 2000
    Report Date
    June 21, 2000
    Manufacturer
    LAERDAL MEDICAL CORP.
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    DEVICE FAILED TO ANALYZE PT RHYTHM. COULDN'T DEFIBRILLATE THE PT. SUBSEQUENT MONITORING WITH ANOTHER DEVICE, 3-4 MINS LATER, SHOWED THE PT WAS IN VENTRICULAR FIBRILLATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTSTART 2000 AUTOMATIC DEFIBRILLATOR MKJ LAERDAL MEDICAL CORP. HEARTSTART 2000 *

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other