BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OBTV CLIENT

    MDR report key: 2023098 · Received February 15, 2011

    Report

    Report Number
    9610816-2011-00087
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Report Date
    February 5, 2011
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    HGM
    PMA / PMN Number
    K970456
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED NO AUDIO ALARMS ON CLIENT ONE AND CLIENT TWO OF THE OBTV MONITOR. NO PT HARM WAS REPORTED. PHILIPS IS IN THE PROCESS OF OBTAINING ADD'L INFO CONCERNING THIS EVENT 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 NO AUDIO ALARMS ON CLIENT ONE AND CLIENT TWO. NO PT HARM WAS REPORTED.

    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