BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX-EMS DEFIBRILLATOR

    MDR report key: 2963046 · Received January 25, 2013

    Report

    Report Number
    1218950-2013-00275
    Event Type
    Malfunction
    Date Received
    January 25, 2013
    Report Date
    January 2, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A PHILIPS FIELD SVC ENGINEER EVALUATED THE DEVICE AND CONFIRMED THE FAILURE. BOTH THE PROCESSOR PCA AND THE THERAPY PCA WERE REPLACED TO RESOLVE THE PROBLEM. THE DEVICE PASSED ALL PERFORMANCE ASSURANCE TESTS AND WAS RETURNED TO USE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE HAS A GENERAL FAILURE CODE (SERVICE REQUIRED MESSAGE DISPLAYED) AND IS LOCKING UP. THERE WAS NO REPORTED PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36208 HEARTSTART MRX-EMS DEFIBRILLATOR MKJ PHILIPS MEDICAL SYSTEMS M3536A

    Patients

    Seq Age Sex Outcome Treatment
    1