BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFE PAK

    MDR report key: 2820412 · Received January 27, 2010

    Report

    Report Number
    2820412
    Event Type
    Injury
    Date Received
    January 27, 2010
    Date of Event
    January 12, 2010
    Report Date
    January 27, 2010
    Manufacturer
    PHSIOCONTROL
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    RESIDENT WENT INTO CARDIAC ARREST AND A CODE WAS CALLED BY THE CLINICAL TEAM. DURING THE CODE, AN AED WAS USED AND ACTIVATED THREE TIMES TO EMIT AN ELECTRICAL CURRENT WHICH IF TAILED TO DO ON THE THREE TIMES USED. EMS ARRIVED TO THE NURSING HOME AND USED THEIR AED AND REGAINED A PULSE, THE RESIDENT WAS TRANSFERRED TO THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFE PAK AED MKJ PHSIOCONTROL LIFEPAK500

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention