BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIVUE MULTI MEASUREMENT SERVER (MMS)

    MDR report key: 2201060 · Received July 1, 2011

    Report

    Report Number
    9610816-2011-00375
    Event Type
    Malfunction
    Date Received
    July 1, 2011
    Report Date
    June 24, 2011
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K030038
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER HAS REPORTED THAT AN MMS MODULE WAS DROPPED AND THE CASE BROKE. BASED ON THE AVAILABLE INFO, PHILIPS CANNOT CONFIRM IF THE DEVICE WAS ACCIDENTALLY DROPPED BY THE USER OR THE DEVICE FELL. PHILIPS WILL REPORT THIS ISSUE IN ABUNDANT CAUTION. NO PT HARM WAS REPORTED. PHILIPS IS IN THE PROCESS OF OBTAINING ADD'L INFO REGARDING THIS INCIDENT 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 HAS REPORTED THAT AN MMS MODULE WAS DROPPED AND THE CASE BROKE.

    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