BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX-EMS DEFIBRILLATOR

    MDR report key: 3003560 · Received February 11, 2013

    Report

    Report Number
    1218950-2013-00485
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Report Date
    January 15, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED AN UNEXPECTED SHUTDOWN DURING USE. NO ADVERSE PATIENT IMPACT WAS REPORTED. THE DEVICE WAS EVALUATED BY A PHILIPS FSE. THE SYMPTOM COULD NOT BE DUPLICATED. MULTIPLE PARTS WERE REPLACED AT THE DISCRETION OF THE TECHNICIAN TO ADDRESS THE ISSUE. THE DEVICE REMAINS AT THE CUSTOMER SITE. BASED ON THE CUSTOMERS REPORT WE ARE CONSIDERING THIS A MALFUNCTION. WE CANNOT DETERMINE THE CAUSE SINCE THE SYMPTOM COULD NOT BE DUPLICATED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN UNEXPECTED SHUTDOWN DURING USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59234 HEARTSTART MRX-EMS DEFIBRILLATOR MKJ PHILIPS MEDICAL SYSTEMS M3536A

    Patients

    Seq Age Sex Outcome Treatment
    1