BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OB TRACEVUE SERVER

    MDR report key: 1787797 · Received July 28, 2010

    Report

    Report Number
    9610816-2010-00227
    Event Type
    Malfunction
    Date Received
    July 28, 2010
    Report Date
    March 25, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    HGM
    PMA / PMN Number
    K051134
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT WHEN THEY CONNECT VIA THE WEB 'SYSTEM' APPEARS "NORMAL" WHILE THE REAL TIME ALERTING IS NO LONGER PRESENT AND IS INTERMITTENT. - TO GE ALARMING/ALERTING TO REAPPEAR THE USER HAS TO LOG OFF THEN BACK ON - THIS IS NOT USER OR PC SPECIFIC. THE RESPONSE CENTER ENGINEER (RCE) HAD THE CUSTOMER CHECK TO SEE IF THERE ARE ANY APPLICATION RELATED ERRORS BEFORE AND AFTER THE PROBLEM HAS BEEN CORRECTED. "THE EQUIPMENT THAT HAD AN ISSUE BELONGED TO THE CUSTOMER (WEB CLIENT MACHINE)." THE RCE CONFIRMED THAT THERE WAS NO ALLEGATION OF A DEATH OR SI. THE RCE WAS NOT AWARE HOW THE CUSTOMER ISSUE WAS RESOLVED. THE PRODUCT REMAINS AT THE CUSTOMER SITE. PHILIPS HAS RECEIVED NO REPORTS SUPPORTING THAT ANY SIMILAR FAILURE HAS BEEN A FACTOR IN A SERIOUS INJURY OR DEATH. GIVEN THAT INCORRECT USER SETTINGS CAN CAUSE THE REPORTED PROBLEM, THE AVAILABLE INFORMATION IS NOT SUFFICIENT TO SUPPORT THAT THIS WAS A MALFUNCTION. ANALYSIS OF COMPLAINT RECORDS SUPPORTS THAT THERE IS NO DESIGN OR LABELING PROBLEM. PHILIPS IS CONSIDERING THAT THIS ISSUE WAS CAUSED BY A MALFUNCTION OF 3RD PARTY COMPUTERS (UNKNOWN MANUFACTURER) THAT HAPPENED ONE TIME. NO FURTHER INVESTIGATION OR ACTON IS WARRANTED. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED INTERMITTENT ALARMING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OB TRACEVUE SERVER HGM PHILIPS MEDICAL SYSTEMS M1383F

    Patients

    Seq Age Sex Outcome Treatment
    1