BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX -EMS DEFIBRILLATOR

    MDR report key: 11294222 · Received February 8, 2021

    Report

    Report Number
    3030677-2021-00278
    Event Type
    Malfunction
    Date Received
    February 8, 2021
    Report Date
    January 27, 2021
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    UDI-DI
    00884838006652
    PMA / PMN Number
    K031187
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT HAS BEEN UPDATED FROM SI TO NAE. SUBMISSION OF A REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, DISTRIBUTOR, MANUFACTURER, OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED TO PHILIPS THAT, WHEN THE USER TRIED TO USE IT FOR A PATIENT, THE DEVICE WAS TURNED ON, BUT THE DEVICE TURNED OFF IMMEDIATELY. IT WAS LATER CLARIFIED THAT THE USER WAS MEASURING NBP FROM A PATIENT IN AN AMBULANCE. WHEN THE USER STARTED NBP MEASUREMENT, AND THE MRX STARTED TO APPLY PRESSURE TO THE NBP CUFF, THE MRX TURNED OFF. THE USER WAITED A FEW MINUTES AND CONFIRMED READY FOR USE STATUS, TURNED ON THE MRX, AND THE MRX SHUT DOWN AGAIN. ANOTHER DEVICE WAS USED TO MEASURE THE PATIENT'S NBP. THE DEVICE WAS IN USE ON A PATIENT AND THERE WAS NO ADVERSE EVENT TO THE PATIENT OR USER. THIS CASE HAS BEEN UPDATED FROM SERIOUS INJURY TO NON ADVERSE EVENT AS ADDITIONAL INFORMATION RECEIVED CLARIFIED THE PROCEDURE DID NOT INVOLVE LIFE SAVING THERAPY.

    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, WHEN THE USER TRIED TO USE IT FOR A PATIENT, THE DEVICE WAS TURNED ON, BUT THE DEVICE TURNED OFF IMMEDIATELY. THE DEVICE WAS REPORTED TO BE IN USE ON A PATIENT, CAUSING A POSSIBLE DELAY IN LIFE SAVING THERAPY AND WILL BE CONSIDERED A SERIOUS INJURY. HOWEVER, NO DIRECT ADVERSE EVENT TO THE PATIENT OR USER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    190674 HEARTSTART MRX -EMS DEFIBRILLATOR DEFIBRILLATOR MKJ PHILIPS MEDICAL SYSTEMS M3536A 00884838006652

    Patients

    Seq Age Sex Outcome Treatment
    1