BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VS3: NBP, SP02, TEMP

    MDR report key: 2113037 · Received May 25, 2011

    Report

    Report Number
    1218950-2011-01344
    Event Type
    Malfunction
    Date Received
    May 25, 2011
    Report Date
    May 9, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MHX
    PMA / PMN Number
    K082280
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED DESCRIPTION NOTES THAT A TECHNICAL MESSAGE WAS DISPLAYED ON THE PT MONITOR "SPEAKER MALFUNCTION" WITH NO AUDIO FUNCTION. NO PT HARM WAS REPORTED. 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 REPORTED DESCRIPTION NOTES THAT A TECHNICAL MESSAGE WAS DISPLAYED ON THE PT MONITOR "SPEAKER MALFUNCTION" WITH NO AUDIO FUNCTION. NO PT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VS3: NBP, SP02, TEMP MHX PHILIPS HEALTHCARE 863073

    Patients

    Seq Age Sex Outcome Treatment
    1