BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX

    MDR report key: 7074434 · Received December 1, 2017

    Report

    Report Number
    1218950-2017-08106
    Event Type
    Malfunction
    Date Received
    December 1, 2017
    Report Date
    November 8, 2017
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    PHILIPS BENCH REPAIR TECHNICIAN PROVIDED A QUOTE FOR REPLACEMENT OF THE THERAPY PCA AND INFORMED THE CUSTOMER THAT THERE IS A GLOBAL SHIP HOLD . THE DEVICE REMAINS AT PHILIPS REPAIR BENCH AND WILL BE RETURNED TO THE CUSTOMER UPON REPLACEMENT OF THE THERAPY PCA OR CUSTOMER'S REFUSAL OF QUOTE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO PHILIPS THAT THE DEVICE HAS A SHOCK EQUIPMENT MALFUNCTION. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO PHILIPS THAT THE DEVICE HAD A SHOCK EQUIPMENT MALFUNCTION. THERE WAS NO REPORTED PATIENT INVOLVEMENT. THE REPORTED PROBLEM COULDN¿T BE VERIFIED OR DUPLICATED IN THE LAB. NO FAULT FOUND (NFF) WITH THIS THERAPY BOARD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    853393 HEARTSTART MRX DEFIBRILLATOR MKJ PHILIPS MEDICAL SYSTEMS M3535A FTHS100200BR

    Patients

    Seq Age Sex Outcome Treatment
    1