BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHILIPS FM 50 FETAL MONITOR AND OB TRACEVUE

    MDR report key: 2443140 · Received January 29, 2012

    Report

    Report Number
    2443140
    Event Type
    Malfunction
    Date Received
    January 29, 2012
    Date of Event
    January 6, 2012
    Report Date
    January 24, 2012
    Manufacturer
    PHILIPS
    Product Code
    HGM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THERE WAS AN OUTAGE THAT IMPACTED THE TRACEVUE DATA ACQUISITION SERVER. TRACINGS FROM FETAL MONITORS WERE NOT ARCHIVING INTO TRACEVUE FOR SEVERAL MINUTES UNTIL THE SERVERS WERE REBOOTED. FOR THIS PARTICULAR PATIENT TRACING, THE FAST UPLOAD OF DATA APPEARS TO NOT HAVE PERFORMED CORRECTLY. THERE IS NO DATA IN THE ELECTRONIC RECORD DURING THE UP LOAD TIME. TRACEVUE INDICATES THAT THE DATA WAS UPLOADED; THERE IS A GAP DURING THE TIME OF THE "UPLOAD" BUT NO DATA. I VERIFIED THE PAPER TRACING IS COMPLETE. THIS BEHAVIOR OF THE UPLOAD FUNCTION FOR THIS FETAL MONITOR-TRACEVUE CONNECTION IS NOT AS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHILIPS FM 50 FETAL MONITOR AND OB TRACEVUE PHILIPS FM 50 FETAL MONITOR AND OB TRACEVUE HGM PHILIPS FM 50 *

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR