BEUDAMED
    FDA Adverse Event Other Summary report: N

    HEARTSTART

    MDR report key: 627201 · Received August 16, 2005

    Report

    Report Number
    9610483-2005-00037
    Event Type
    Other
    Date Received
    August 16, 2005
    Date of Event
    October 15, 2004
    Report Date
    October 20, 2004
    Manufacturer
    LAERDAL MEDICAL A/S
    Product Code
    MKJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING AN INCIDENT IN 2004 INVOLVING A PT IN CARDIAC ARREST, THE UNIT POWERED OFF WITH A "LOW BATTERY" PROMPT. THE BATTERY WAS REPLACED AND THE SAME THING HAPPENED. ALS INTERVENED AND TRANSPORTED THE PT TO A HOSP. A CO-WORKER SAID THE PT COMPLAINED OF A HEADACHE AND SUDDENLY COLLAPSED. CPR WAS INITIATED IMMEDIATELY, DURING BATTERY CHANGE AND AFTER THE SECOND SHUT DOWN WITH "LOW BATTERY" PROMPT. A BAG VALVE MASK WITH OXYGEN WAS USED AT THE SCENE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTSTART * MKJ LAERDAL MEDICAL A/S HS 3000 9704

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other