BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX -EMS DEFIBRILLATOR

    MDR report key: 9174679 · Received October 10, 2019

    Report

    Report Number
    1218950-2019-07709
    Event Type
    Malfunction
    Date Received
    October 10, 2019
    Report Date
    September 17, 2019
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    UDI-DI
    00884838006652
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFO: ADDED FAILURE ANALYSIS INFO. 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 WAS NOT RECOGNIZING THE THERAPY CABLE AND TEST LOAD. THERE WAS NO REPORTED PATIENT INVOLVEMENT OR ADVERSE PATIENT/USER IMPACT AS A RESULT OF THE ALLEGED FAILURE. ONE POWER PCA WAS RETURNED TO THE FAILURE ANALYSIS LAB FOR EVALUATION. THE PCA PASSED ALL THE TESTS. NO FAULT FOUND (NFF) WITH THIS POWER BOARD.

    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 DEVICE WAS NOT RECOGNIZING THE THERAPY CABLE AND TEST LOAD. THERE WAS NO REPORTED PATIENT INVOLVEMENT OR ADVERSE PATIENT/USER IMPACT AS A RESULT OF THE ALLEGED FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    968451 HEARTSTART MRX -EMS DEFIBRILLATOR DEFIBRILLATOR MKJ PHILIPS MEDICAL SYSTEMS M3536A 00884838006652

    Patients

    Seq Age Sex Outcome Treatment
    1