BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX -EMS DEFIBRILLATOR

    MDR report key: 4202690 · Received March 19, 2014

    Report

    Report Number
    1218950-2014-01557
    Event Type
    Malfunction
    Date Received
    March 19, 2014
    Report Date
    February 20, 2014
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS EVALUATED BY A PHILIPS BENCH TECHNICIAN. THE ISSUE WAS FURTHER CLARIFIED AS A PADS CABLE FAILURE AND AN ECG FRONT-END FAILURE. THE PROCESSOR PCA WAS DETERMINED TO BE FAULTY. THE PROCESSOR PCA WAS REPLACED TO RESOLVE THE ISSUE. THE DEVICE PASSED ALL PERFORMANCE ASSURANCE TESTING AND WAS RETURNED TO THE CUSTOMER. THIS WAS A MALFUNCTION OF THE PROCESSOR PCA.

    Description of Event or Problem · 1

    IT WAS REPORTED TO PHILIPS HEALTHCARE THAT THE HEARTSTART MRX DEFIBRILLATOR HAD A RED X AND AN ECG MALFUNCTION. THE ISSUE WAS FURTHER CLARIFIED BY THE PHILIPS BENCH REPAIR TECH, AS A PADS CABLE FAILURE WITH AN ECG FRONT-END FAILURE. THERE WAS NO REPORTED PT INVOLVEMENT AND/OR IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    165134 HEARTSTART MRX -EMS DEFIBRILLATOR MKJ PHILIPS MEDICAL SYSTEMS M3536A

    Patients

    Seq Age Sex Outcome Treatment
    1