BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MP30 INTELLIVUE PATIENT MONITOR

    MDR report key: 2210033 · Received August 2, 2011

    Report

    Report Number
    9610816-2011-00454
    Event Type
    Injury
    Date Received
    August 2, 2011
    Report Date
    July 27, 2011
    Manufacturer
    PHILIPS MEDICAL SYSTEMS.
    Product Code
    MHX
    PMA / PMN Number
    K030038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT AN IV POLE HIT THE BEDSIDE MONITOR WHEN THE BED WAS BEING RAISED, CAUSING THE BESIDE MONITOR TO BECOME FREE. THE MONITOR FELL ON A PT, CAUSING INJURY. IT WAS REPORTED TO PHILIPS THAT THE BED HAD BEEN PLACED UNDER THE MONITOR, CONTRARY TO THE SPECIFICATIONS FOUND IN THE DEVICE LABELING. THE EXTENT OF THE PT INJURY WAS NOT REPORTED TO PHILIPS. PHILIPS IS IN THE PROCESS OF OBTAINING ADDITIONAL 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 AN IV POLE HIT THE BEDSIDE MONITOR WHEN THE BED WAS BEING RAISED, CAUSING THE BEDSIDE MONITOR TO BECOME FREE. THE MONITOR FELL ON A PT, CAUSING INJURY.

    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