BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX -EMS DEFIBRILLATOR

    MDR report key: 8726770 · Received June 24, 2019

    Report

    Report Number
    1218950-2019-04490
    Event Type
    Malfunction
    Date Received
    June 24, 2019
    Report Date
    May 31, 2019
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO PHILIPS THAT THE THERAPY KNOB FOR THE DEVICE WAS FAULTY AND NEEDED TO BE REPLACED. THE CUSTOMER REQUESTED THAT THE DEVICE BE RETURNED FOR BENCH REPAIR. WHILE THE DEVICE WAS REPORTED TO HAVE BEEN IN CLINICAL USE AT THE TIME OF THE ALLEGED FAILURE, THERE HAS BEEN NO REPORT OF AN ADVERSE PATIENT/USER IMPACT AS A RESULT OF THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    523084 HEARTSTART MRX -EMS DEFIBRILLATOR DEFIBRILLATOR MKJ PHILIPS MEDICAL SYSTEMS M3536A

    Patients

    Seq Age Sex Outcome Treatment
    1