BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIVUE MULTI MEASUREMENT SERVER (MMS)

    MDR report key: 1884712 · Received October 25, 2010

    Report

    Report Number
    9610816-2010-00652
    Event Type
    Malfunction
    Date Received
    October 25, 2010
    Report Date
    July 28, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K030038
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): NO ADVERSE PT EVENT WAS REPORTED TO HAVE RESULTED FROM THE OCCURRENCE. THIS IS NOT BEING CONSIDERED A DEVICE MALFUNCTION. DAMAGE SUSTAINED IN THE FALL IS NOT CONSIDERED AS A MALFUNCTION. NO INDICATION OF A DEFECTIVE MOUNTING SOLUTION, OR ANY OTHER MECHANICAL DEFECT CONTRIBUTING TO THE DROP, WAS PROVIDED NOR WAS A DEFECTIVE MOUNTING OR DEFECTIVE PART ALLEGED TO HAVE CAUSED. IT WAS NOT EXPRESSED AS AN UNEXPECTED DROP WHICH CAUSED THAT THE MMS BROKE. PLEASE NOTE THAT THIS DEVICE FAILURE IS CONSIDERED A PHYSICAL DAMAGE MOST CONSISTENT WITH IMPROPER USER HANDLING AND THEREFORE, NOT A MALFUNCTION OF DESIGN OR LABELING; WE WILL CONSIDER THIS AS DUE TO USE OUTSIDE NORMAL AND EXPECTED. 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 MONITOR FELL AND WAS DAMAGED. NO PT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTELLIVUE MULTI MEASUREMENT SERVER (MMS) MHX PHILIPS MEDICAL SYSTEMS M3001A

    Patients

    Seq Age Sex Outcome Treatment
    1