BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MP30 INTELLIVUE PATIENT MONITOR

    MDR report key: 1902854 · Received November 12, 2010

    Report

    Report Number
    9610816-2010-00731
    Event Type
    Malfunction
    Date Received
    November 12, 2010
    Report Date
    November 3, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K030038
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED TO PHILIPS THAT THE MP30 MONITOR, MOUNTING ARM AND WALL CHANNEL FELL FROM THE WALL. THE HOSPITAL BIOMEDICAL ENGINEERING MGR ALSO NOTED THAT THIS WAS NOT A PHILIPS ISSUE, AS IT WAS RELATED TO THE INSTALLATION OF THE WALL CHANNEL (NOT INSTALLED BY PHILIPS). THERE WAS NO DEVICE OF MOUNT MALFUNCTION. THIS IS RELATED TO INCORRECT INSTALLATION OF THE WALL CHANNEL BY THE HOSPITAL (OR HOSPITAL CONTRACTOR). 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 CUSTOMER REPORTED THAT THE MP30 MONITOR, MOUNTING ARM AND WALL CHANNEL FELL FROM THE WALL.

    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