BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MP30 INTELLIVUE PATIENT MONITOR

    MDR report key: 1604566 · Received November 12, 2009

    Report

    Report Number
    9610816-2009-00202
    Event Type
    Malfunction
    Date Received
    November 12, 2009
    Report Date
    November 11, 2009
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K03003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THAT WHEN A MEMBER OF THE CLEANING STAFF MOVED THE OVERHEAD ARM TO WHICH THE MP30 MONITOR/GCX MOUNT WAS ATTACHED, THE GCX MOUNT FAILED, AND THE MONITOR FELL TO THE FLOOR. THE PICTURES OF THE FAILED MOUNT INDICATE METAL SHEARING FROM FORCE OUTSIDE NORMAL AND EXPECTED USE. 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. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHEN A MEMBER OF THE CLEANING STAFF MOVED THE OVERHEAD ARM TO WHICH THE MP30 MONITOR/GCX MOUNT WAS ATTACHED, THE GCX MOUNT FAILED, AND THE MONITOR FELL TO THE FLOOR.

    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