BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIVUE MULTI MEASUREMENT SERVER (MMS)

    MDR report key: 1813263 · Received August 18, 2010

    Report

    Report Number
    9610816-2010-00276
    Event Type
    Malfunction
    Date Received
    August 18, 2010
    Report Date
    July 19, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K030038
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE REPORT FROM THE CUSTOMER INDICATES THAT THE WAVEFORMS WERE LOST FOR AN UNDETERMINED TIME PERIOD. THE LIMITED AVAILABLE INFORMATION IS NOT SUFFICIENT TO SUPPORT THAT THERE WAS ANY HEALTH RISK. PHILIPS IS REPORTING THIS EVENT IN ABUNDANT CAUTION. 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 REPORT FROM THE CUSTOMER INDICATES THAT THE WAVEFORMS WERE LOST FOR AN UNDETERMINED TIME PERIOD.

    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