BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OBTV TRACEVUE CLIENT

    MDR report key: 1731330 · Received June 18, 2010

    Report

    Report Number
    9610816-2010-00176
    Event Type
    Malfunction
    Date Received
    June 18, 2010
    Report Date
    May 19, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    HGM
    PMA / PMN Number
    K970456
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED A FAILURE TO ALARM. THE RESPONSE CENTER ENGINEER (RCE) LEARNED THAT THE CUSTOMER DID NOT HAVE ALERT DISTRIBUTION SET FOR THE BEDS. THE RCE GUIDED THE CUSTOMER THROUGH THE ALERT DISTRIBUTION STEPS. THE ALERTS ARE NOW BEING HEARD AT THE NURSES' STATION. THIS IS BEING CONSIDERED A CONFIGURATION ISSUE AND NOT A PRODUCT MALFUNCTION. THE CONFIGURATION ISSUE WAS CONFIRMED BY THE RCE. DEVICE LABELING (IFU) ADEQUATELY DESCRIBES CONFIGURATION OF ALERTS. NO FURTHER INVESTIGATION OR ACTION IS WARRANTED. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THERE WAS A FAILURE TO ALARM.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1