BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MP30 INTELLIVUE PATIENT MONITOR

    MDR report key: 1853794 · Received October 1, 2010

    Report

    Report Number
    9610816-2010-00550
    Event Type
    Malfunction
    Date Received
    October 1, 2010
    Report Date
    August 12, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K030038
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER REPORTED THAT A MONITOR FELL. NO PT HARM WAS REPORTED. AS THIS IS A PORTABLE MONITOR, THE AVAILABLE INFORMATION IS NOT SUFFICIENT TO SUPPORT THAT THIS WAS AN UNEXPECTED FALL OR A MALFUNCTION. 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 A MONITOR FELL. 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