BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX MONITOR/DEFIB

    MDR report key: 11905584 · Received May 29, 2021

    Report

    Report Number
    3030677-2021-11861
    Event Type
    Malfunction
    Date Received
    May 29, 2021
    Date of Event
    May 4, 2021
    Manufacturer
    PHILIPS NORTH AMERICA LLC
    Product Code
    MKJ
    UDI-DI
    00884838000018
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT EVALUATION: THE CUSTOMER REQUESTED THAT A PHILIPS FIELD SERVICE ENGINEER (FSE) BE DISPATCHED TO THE CUSTOMER SITE. THE REPORTED ISSUE WAS CONFIRMED AND TRACED TO A FAULTY ECG CABLE CUSTOMER RESOLUTION AND CONCLUSION: UPON CONCLUSION OF THE EVALUATION, IT WAS DETERMINED THAT THIS WAS A MALFUNCTION OF THE ECG CABLE. THE ECG CABLE WAS REPLACED TO RESOLVE THE REPORTED ISSUE. THE DEVICE REMAINS AT THE CUSTOMER SITE AND NO FURTHER EVALUATION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED TO PHILIPS THAT PACEMAKER FUNCTION WAS INCORRECT. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    802087 HEARTSTART MRX MONITOR/DEFIB DEFIBRILLATOR MKJ PHILIPS NORTH AMERICA LLC M3535A 00884838000018

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown