BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX - EMS DEFIBRILLATOR

    MDR report key: 2233105 · Received July 22, 2011

    Report

    Report Number
    1218950-2011-02116
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Report Date
    June 27, 2011
    Manufacturer
    PHILIPS HEALTHCARE - ANDOVER
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THE DEVICE FAILED OPS CHECK AND IS CHIRPING. THERE WAS NO REPORTED PT INVOLVEMENT. THE CUSTOMER EVALUATED THE DEVICE WITH THE HELP OF THE RESPONSE CENTER AND CONFIRMED THE BATTERIES WERE FAULTY. THE SYSTEM IS WORKING AS EXPECTED. WE WILL CONSIDER THIS A MALFUNCTION OF THE BATTERIES THAT CAUSED THE DEVICE TO CHIRP AND FAIL OPS CHECK.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE DEVICE FAILED OPS CHECK AND IS CHIRPING. THERE WAS NO REPORTED PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTSTART MRX - EMS DEFIBRILLATOR MKJ PHILIPS HEALTHCARE - ANDOVER M3536A

    Patients

    Seq Age Sex Outcome Treatment
    1