BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX -EMS DEFIBRILLATOR

    MDR report key: 3823127 · Received April 30, 2014

    Report

    Report Number
    1218950-2014-02401
    Event Type
    Malfunction
    Date Received
    April 30, 2014
    Report Date
    April 5, 2014
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED BY THE CUSTOMER THAT WHILE MONITORING THE HEARTSTART MRX INTERMITTENTLY "GOES OFF". IT WAS LATER CLARIFIED AND CONFIRMED BY THE PHILIPS AUTHORIZED SUPPORT DISTRIBUTOR THAT THE RFU INDICATED HAD THE RED CROSS WITH THE DEVICE FAILING OP-CHECK FOR DEFIB TEST. THERE WAS NO REPORTED PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259544 HEARTSTART MRX -EMS DEFIBRILLATOR MKJ PHILIPS MEDICAL SYSTEMS M3536A

    Patients

    Seq Age Sex Outcome Treatment
    1