BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX -EMS DEFIBRILLATOR

    MDR report key: 7373382 · Received March 27, 2018

    Report

    Report Number
    1218950-2018-02859
    Event Type
    Malfunction
    Date Received
    March 27, 2018
    Report Date
    February 27, 2018
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    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 THE DEVICE FAILED THE DEFIBRILLATOR TEST. THERE WAS NO REPORTED PATIENT INVOLVEMENT/ADVERSE PATIENT IMPACT. A PROCESSOR PCA WAS RECEIVED IN THE FAILURE ANALYSIS LAB. THE PROCESSOR PCA WAS TESTED AND PASSED ALL TESTING. THE REPORTED PROBLEM WAS NOT DUPLICATED. NO FAULT FOUND (NFF) WITH THIS PROCESSOR BOARD.

    Description of Event or Problem · 1

    IT WAS REPORTED TO PHILIPS THAT THE DEVICE FAILED DEFIBRILLATOR TEST. THERE WAS NO REPORTED PATIENT INVOLVEMENT/ADVERSE PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216676 HEARTSTART MRX -EMS DEFIBRILLATOR DEFIBRILLATOR MKJ PHILIPS MEDICAL SYSTEMS M3536A

    Patients

    Seq Age Sex Outcome Treatment
    1