BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MP30 INTELLIVUE PATIENT MONITOR

    MDR report key: 1546652 · Received August 11, 2009

    Report

    Report Number
    9610816-2009-00140
    Event Type
    Malfunction
    Date Received
    August 11, 2009
    Report Date
    February 26, 2009
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K03003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HOSPITAL BIOMEDICAL ENGINEER TECHNICIAN REPORTED TO THE PHILIPS FIELD SERVICE ENGINEER (FSE) THAT WHILE EMERGENCY MEDICAL TEAM (EMT) STAFF WERE MOVING A PATIENT INTO THE ROOM, THE MONITOR WAS MOVED, AND IT FELL FROM THE WALL WITH THE GCX MOUNT ATTACHED. THERE WAS NO PATIENT INCIDENT OR INJURY. A FOLLOW-UP CALL WAS PLACED TO THE FSE, WHO CONFIRMED THAT THE ISSUE WAS THE RESULT OF INCORRECT ASSEMBLY OF AN ADAPTER PLATE TO THE GCX MOUNT TO ALLOW IT TO BE MOUNTED TO THE HOSPITAL'S AMICO RAIL. THE INCORRECT SCREW LENGTH (TOO SHORT FOR ADEQUATE ENGAGEMENT IN THE MOUNT) AND INCORRECT THREAD TYPE (FINE THREAD INSTEAD OF COARSE MACHINE THREAD) WERE USED BY HOSPITAL MEDICAL EQUIPMENT STAFF TO MOUNT THE ADAPTER PLATE TO THE GCX MOUNT. WHEN THE MONITOR WAS MOVED, THE SCREWS PULLED OUT OF THE THREADS IN WHICH THEY WERE MINIMALLY ENGAGED. THE FSE REPORTED THAT THE HOSPITAL'S MEDICAL EQUIPMENT STAFF WILL BE RE-TAPPING THE THREADS ON ALL 7 OF THE MOUNTS THAT THEY HAD INCORRECTLY ATTACHED TO ADAPTER PLATES. THE HOSPITAL WILL ALSO INSTALL GCX 6" WALL CHANNELS TO ATTACH THE MOUNTS TO (RATHER THAN ATTEMPT ATTACHING THEM TO THE AMICO RAIL AGAIN). THE FSE SAID THAT THE HOSPITAL'S MEDICAL EQUIPMENT STAFF HAS TAKEN RESPONSIBILITY FOR THIS ISSUE, AND THAT NO FURTHER ACTION IS REQUIRED OF PHILIPS. THE FSE ALSO REPORTED THAT THERE WAS NO DAMAGE TO THE MONITOR, AS THE NURSE WAS MOVING THE MONITOR AT THE TIME HARDWARE FAILED. THIS IS NOT BEING CONSIDERED A PHILIPS DEVICE OR GCX MOUNT MALFUNCTION. NO FURTHER INVESTIGATION OR ACTION WARRANTED. (B) (4)

    Description of Event or Problem · 1

    THE HOSPITAL BIOMEDICAL ENGINEERING TECHNICIAN REPORTED THAT WHILE EMERGENCY MEDICAL TEAM (EMT) STAFF WERE MOVING A PATIENT INTO THE ROOM, THE MONITOR WAS MOVED, AND IT FELL FROM THE WALL WITH THE GCX MOUNT ATTACHED.

    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