BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MP30 INTELLIVUE PATIENT MONITOR

    MDR report key: 2896420 · Received November 20, 2012

    Report

    Report Number
    9610816-2012-00475
    Event Type
    Malfunction
    Date Received
    November 20, 2012
    Report Date
    October 23, 2012
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K030038
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT THEIR MP30 IS NOT MEASURING OF DISPLAYING ACCURATE, UPDATED SPO2 MEASUREMENTS. 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 CUSTOMER REPORTED THAT THEIR MP30 IS NOT RECORDING, MEASURING OR UPDATING ACCURATE SPO2 SATURATIONS. NO PT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MP30 INTELLIVUE PATIENT MONITOR MHX PHILIPS MEDICAL SYSTEMS M8002A

    Patients

    Seq Age Sex Outcome Treatment
    1