BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OBTV CLIENT

    MDR report key: 2060637 · Received April 8, 2011

    Report

    Report Number
    9610816-2011-00195
    Event Type
    Malfunction
    Date Received
    April 8, 2011
    Report Date
    March 20, 2011
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    HGM
    PMA / PMN Number
    K970456
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER REPORTED THAT THE ALARMS WERE OFF AND THEY WERE UNABLE TO TURN THEM BACK ON. WHILE THE DEVICE DISPLAY PROVIDES VISUAL INDICATORS OF THE ALARMING STATE OF THE MONITOR, THE USER MAY NOT RECOGNIZE THE LACK OF ALARMS AND THIS MAY RESULT IN THE FAILURE OR THE PATIENT NEED FOR ADDITIONAL THERAPY. THE AVAILABLE INFORMATION SUPPORTS THAT THE PROBLEM WITH THIS DEVICE WAS DUE TO A USER TURNING DOWN THE VOLUME ON THE OBTV DEVICE. PHILIPS IS IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION REGARDING THIS INCIDENT AND THE COMPLAINT IS STILL UNDER INVESTIGATION. A FINAL REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE ALARMS WERE OFF AND THEY WERE UNABLE IT TO TURN THEM BACK ON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OBTV CLIENT HGM PHILIPS MEDICAL SYSTEMS M1382E

    Patients

    Seq Age Sex Outcome Treatment
    1