BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAERDAL HEARTSTART 1000

    MDR report key: 300674 · Received October 16, 2000

    Report

    Report Number
    MW1020167
    Event Type
    Malfunction
    Date Received
    October 16, 2000
    Date of Event
    September 28, 2000
    Report Date
    October 16, 2000
    Manufacturer
    LAERDAL MEDICAL CORP.
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ELDERLY FEMALE CARDIAC ARREST. AUTOMATIC EXTERNAL DEFIBRILLATOR (AED) APPLIED WITH AED UNIT FAILURE. UNIT FAILED TO DELIVER SHOCK WHEN SHOCKABLE RHYTHM PRESENTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAERDAL HEARTSTART 1000 SEMI-AUTOMATIC DEFIBRILLATOR MKJ LAERDAL MEDICAL CORP. HS 1000S *

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Other