BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OB TRACEVUE SERVER

    MDR report key: 1813387 · Received August 20, 2010

    Report

    Report Number
    9610816-2010-00347
    Event Type
    Malfunction
    Date Received
    August 20, 2010
    Report Date
    July 28, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    HGM
    PMA / PMN Number
    K970456
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER REPORTED, THE DEVICE FAILED TO ALARM. NO PT HARM WAS REPORTED. PHILIPS IS IN THE PROCESS OF OBTAINING ADDITIONAL 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 A FAILURE TO ALARM. NO PT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OB TRACEVUE SERVER HGM PHILIPS MEDICAL SYSTEMS M1395E

    Patients

    Seq Age Sex Outcome Treatment
    1