BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MP30 INTELLIVUE PATIENT MONITOR

    MDR report key: 1489751 · Received August 10, 2009

    Report

    Report Number
    9610816-2009-00144
    Event Type
    Malfunction
    Date Received
    August 10, 2009
    Report Date
    December 10, 2008
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K03003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HOSPITAL BIOMEDICAL ENGINEER CALLED THE PHILIPS PROJECT CONSULTANT AND REPORTED THAT THE GCX VHM MOUNT AND GCX WALL CHANNEL (TO WHICH THE M8002A INTELLIVUE PT MONITOR WAS ATTACHED) FELL FROM THE WALL. THE BIOMEDICAL ENGINEER ALSO REPORTED THAT THE WALL CHANNEL WAS INCORRECTLY INSTALLED (INCORRECT HARDWARE FOR THE APPLICATION). THE PROJECT CONSULTANT VERIFIED THAT THE WALL CHANNEL WAS NOT INSTALLED BY PHILIPS, AND INFORMED THE BIOMEDICAL ENGINEER OF THIS. A F/U CALL WAS PLACED TO THE BIOMEDICAL ENGINEER, WHO SAID THAT THE ISSUE WAS WITH THE HOSPITAL INSTALLED WALL CHANNEL. THE WALL CHANNEL HAD BEEN IN USE PREVIOUSLY TO SUPPORT A SMALL MONITOR. THE MP30 MONITOR WITH THE GCX MOUNTING ARM WAS LATER MOUNTED TO THE WALL CHANNEL. THE WALL CHANNEL, WITH THE GCX MOUNTING ARM AND MP30 MONITOR FELL TO THE FLOOR. THERE WAS NO PT INCIDENT. THE BIOMEDICAL ENGINEER STATED THAT A VERY SMALL CHIP WAS NOTED IN THE MP30 MONITOR. THE MONITOR WAS SAFETY TESTED AND IS FULLY FUNCTIONAL. THE BIOMEDICAL ENGINEER STATED THAT THE WALL CHANNEL HAS BEEN RELOCATED (TO A METAL STUD IN THE WALL). THE BIOMEDICAL ENGINEER SAID THAT THIS WAS A HOSPITAL ISSUE, AND THAT NO RESPONSE LETTER IS NEEDED. THE BIOMEDICAL ENGINEER ALSO SAID THAT THE HOSPITAL BIOMEDICAL ENGINEERING STAFF IS IN THE PROCESS OF CHECKING OTHER WALL CHANNELS AND WILL RELOCATE THEM AS NECESSARY. THIS IS NOT BEING CONSIDERING A PHILIPS DEVICE, PRODUCT, OR INSTALLATION MALFUNCTION. NO FURTHER INVESTIGATION OR ACTION IS WARRANTED. (B) (4).

    Description of Event or Problem · 1

    THE HOSPITAL BIOMEDICAL ENGINEER CALLED THE PHILIPS PROJECT CONSULTANT AND REPORTED THAT THE GCX VHM MOUNT AND GCX WALL CHANNEL (TO WHICH THE M8002A INTELLIVUE PT MONITOR WAS ATTACHED) 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