BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIVUE MULTI MEASUREMENT SERVER X2

    MDR report key: 2102578 · Received May 19, 2011

    Report

    Report Number
    9610816-2011-00264
    Event Type
    Malfunction
    Date Received
    May 19, 2011
    Report Date
    May 12, 2011
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K071426
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER REPORTED THAT THE DEVICE GIVES NO AUDIBLE ALARM TONES, AND DISPLAYS A SPEAKER MALFUNCTION INOP. NO PATIENT HARM WAS REPORTED. THE AVAILABLE INFORMATION DOES NOT SUPPORT THAT THIS FAILURE IS PART OF ANY PREVIOUSLY INVESTIGATED FAILURE MODE. PHILIPS IS IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION 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 THE DEVICE GIVES NO AUDIBLE ALARM TONES, AND DISPLAYS A SPEAKER MALFUNCTION INOP. NO PATIENT 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