BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MP30 INTELLIVUE PATIENT MONITOR

    MDR report key: 2070799 · Received April 15, 2011

    Report

    Report Number
    9610816-2011-00203
    Event Type
    Malfunction
    Date Received
    April 15, 2011
    Report Date
    March 18, 2011
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K030038
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT A MONITOR FELL AND WAS DAMAGED. NO PT HARM WAS REPORTED. PHILIPS HAS NOT RECEIVED THE REQUESTED INFO REGARDING WHETHER THIS WAS AN ACCIDENTAL DROP BY A USER OR IF IT INVOLVED ANY FAILURE OF MOUNTING EQUIPMENT. PHILIPS IS IN THE PROCESS OF OBTAINING ADD'L INFO 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 AND WAS DAMAGED. 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