BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIVUE MULTI MEASUREMENT SERVER (MMS)

    MDR report key: 2243808 · Received July 29, 2011

    Report

    Report Number
    9610816-2011-00435
    Event Type
    Malfunction
    Date Received
    July 29, 2011
    Report Date
    July 22, 2011
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K030038
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT A COMPONENT OF THEIR MULTI MEASUREMENT SERVER (MMS) BURNED A HOLE IN THE PLASTIC COVER AND STOPPED WORKING. THE CUSTOMER ALSO STATED THAT THEY COULD SMELL THE DEVICE BURNING. NO PT ALARM WAS REPORTED. PHILIPS CONSIDERS THIS BREAK OF THE DEVICE CASE BY HEAT FROM A MALFUNCTION AS A POSSIBLE HEALTH RISK. PHILIPS IS IN THE PROCESS OF OBTAINING ADDITIONAL 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 REPORTED THAT A COMPONENT OF THEIR MULTI MEASUREMENT SERVER (MMS) BURNED A HOLE IN THE PLASTIC COVER. 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