BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIVUE MULTI MEASUREMENT SERVER X2

    MDR report key: 1821588 · Received August 27, 2010

    Report

    Report Number
    9610816-2010-00311
    Event Type
    Malfunction
    Date Received
    August 27, 2010
    Report Date
    July 28, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K071426
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER REPORTED THAT X2 MONITORS HAVE FALLEN DUE TO THE STORAGE HOOK. NO PT HARM WAS REPORTED. PHILIPS IS REPORTING THIS FAILURE BECAUSE THE INITIAL REPORT INDICATES THAT ONE MORE X2 MONITORS HAVE FALLEN. IF A MONITOR FALLS UNEXPECTEDLY AND HITS A PT, THIS COULD RESULT IN A SERIOUS INJURY. ALL AVAILABLE INFO SUPPORTS THAT ANY FALL WAS DUE TO PHYSICAL DAMAGE TO THE STORAGE HOOK. THE AVAILABLE INFO IS FULLY CONSISTENT WITH BEING DUE TO USE OUTSIDE NORMAL AND EXPECTED. PHILIPS IS IN THE PROCESS OF OBTAINING ADD'L 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 X2 MONITORS HAVE FALLEN DUE TO THE STORAGE HOOK. 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