BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX

    MDR report key: 2802541 · Received September 20, 2012

    Report

    Report Number
    2802541
    Event Type
    Malfunction
    Date Received
    September 20, 2012
    Date of Event
    May 15, 2012
    Report Date
    September 20, 2012
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    LDD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ROUTINE CHECK OF THE DEFIBRILLATOR DONE EVERY SHIFT AS PER POLICY. THE DEFIBRILLATOR CHARGE BUTTON DID NOT INITIATE A CHARGE WHEN TESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTSTART MRX DC-DEFIBRILLATOR, HIGH ENERGY, (INCLUDING PADDLES) LDD PHILIPS MEDICAL SYSTEMS M3535A *

    Patients

    Seq Age Sex Outcome Treatment
    1 *