BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VM6

    MDR report key: 2841417 · Received October 23, 2012

    Report

    Report Number
    1218950-2012-03528
    Event Type
    Malfunction
    Date Received
    October 23, 2012
    Report Date
    September 23, 2012
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K082280
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED DESCRIPTION NOTES THAT THE MONITOR IS ALWAYS SHOWING SATURATIONS (SPO2 READINGS) OF 100%. NO PT HARM WAS REPORTED. PHILIPS HAS RECEIVED REPORTS WHERE INACCURATELY HIGH SPO2 READINGS HAVE LED TO FAILURE TO ALARM WHEN PTS HAVE DESATURATED. SINCE THIS MEASUREMENT AND ALARM IS INDICATIVE OF NEED FOR EMERGENT CARE, THIS DELAY OR LACK OF ALARM COULD HAVE RESULTED IN DELAY IN PROVIDING EMERGENT CARE IF IT WERE TO RECUR. 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 REPORTED DESCRIPTION NOTES THAT THE MONITOR IS ALWAYS SHOWING SATURATIONS (SPO2 READINGS) OF 100%. NO PT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VM6 MHX PHILIPS MEDICAL SYSTEMS 863064

    Patients

    Seq Age Sex Outcome Treatment
    1