BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIVUE MULTI MEASUREMENT SERVER X2

    MDR report key: 1850039 · Received September 28, 2010

    Report

    Report Number
    9610816-2010-00528
    Event Type
    Malfunction
    Date Received
    September 28, 2010
    Report Date
    August 11, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K071426
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT ALARMS WERE NOT BEING DISPLAYED AS EXPECTED. NO PT HARM WAS REPORTED. THE INITIAL INFO SUPPORTS THAT THE HOSPITAL WANTED ASSISTANCE WITH ALARM OVERVIEW CONFIGURATION AND THAT THERE WAS NO DEVICE MALFUNCTION OR DESIGN PROBLEM. 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 THAT ALARMS WERE NOT BEING DISPLAYED AS EXPECTED. NO PT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTELLIVUE MULTI MEASUREMENT SERVER X2 MHX PHILIPS MEDICAL SYSTEMS M3002A

    Patients

    Seq Age Sex Outcome Treatment
    1