BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHILIPS M3002A X2 MONITOR/MODULE

    MDR report key: 8908567 · Received August 19, 2019

    Report

    Report Number
    3007409280-2019-00006
    Event Type
    Malfunction
    Date Received
    August 19, 2019
    Date of Event
    July 29, 2019
    Report Date
    July 30, 2019
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC.
    Product Code
    MHX
    PMA / PMN Number
    K130849
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION. VISUAL INSPECTION WAS PERFORMED AND FOUND NO ANOMALIES. TECHNICAL EVALUATION WAS PERFORMED WHICH CONFIRMED THE REPORTED ISSUE OF THERE BEING NO ECG WAVEFORMS ON THE DISPLAY. THE ECG PCB BOARD WAS REPLACED. THE TECHNICIAN CHECKED FOR CASE DAMAGE, INSPECTED THE CIRCUIT BOARDS, CALIBRATED THE NIBP, UPDATED THE SOFTWARE TO C00 C01 C13 C15 C20 YDS, SET THE SOFTWARE TO H.15.41, AND TESTED THE DEVICE ON A SIMULATOR. THE DISPLAY TEST, ECG TEST, IBP TEST, NIBP TEST, ON/OFF POWER TEST, SPO2, TEMPERATURE TEST, AND FINAL VISUAL INSPECTION ALL PASSED. BASED ON THE REPORTED EVENT AND THE RETURN DEVICE EVALUATION IT WAS DETERMINED THAT THE ROOT CAUSE FOR THE FAILURE TO DISPLAY ECG WAVEFORMS WAS DUE TO AGED PARTS AND DETERMINED THAT THIS WAS NOT RELATED TO A PREVIOUS REPAIR. NO ADDITIONAL INVESTIGATION IS REQUIRED. THIS TYPE OF EVENT WILL CONTINUE TO BE MONITORED.

    Description of Event or Problem · 1

    REPORTEDLY, POST REPAIR, DURING RETURN FROM VENDOR INSPECTION THE DEVICE DID NOT DISPLAY ECG WAVE FORMS. THE DEVICE WAS TESTED WITH PHILIPS CABLES. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    700517 PHILIPS M3002A X2 MONITOR/MODULE MONITOR MHX PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1