BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX

    MDR report key: 3060101 · Received March 20, 2013

    Report

    Report Number
    1218950-2013-00990
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Report Date
    March 4, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED A FAILURE TO DISCHARGE IN TESTING. THE DEVICE WAS EVALUATED LOCALLY BY PHILIPS AND THE REPORTED SYMPTOM COULD NOT BE REPRODUCED. AFTER PASSING ALL PERFORMANCE EVAL TESTING THE DEVICE WAS RETURNED TO USE. THERE IS NO INFO SUPPORTING THAT A MALFUNCTION OF THE DEVICE OCCURRED. WE ARE UNABLE TO DETERMINE THE CAUSE AS THE SYMPTOM WAS NOT REPRODUCED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A FAILURE TO DISCHARGE IN TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116258 HEARTSTART MRX MKJ PHILIPS MEDICAL SYSTEMS M3535A

    Patients

    Seq Age Sex Outcome Treatment
    1