BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIVUE MX700 PATIENT MONITOR

    MDR report key: 4863426 · Received June 23, 2015

    Report

    Report Number
    9610816-2015-00125
    Event Type
    Malfunction
    Date Received
    June 23, 2015
    Report Date
    May 29, 2015
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K110622
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    SERVICE PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE NURSE WAS USING THE HANDLE ON THE MOUNTING ARM TO ADJUST THE HEIGHT OF THE MONITOR AND IT BROKE OFF, CAUSING THE MONITOR TO FALL AND HIT THE NURSE ON THE HEAD. THE MX700 MONITOR WITH THE SERIAL NUMBER (B)(4) WAS MOUNTED ON THE M1180A MOUNT. THE NURSE WAS DOING A CAR SEAT TEST ON A BABY IN THE NICU ¿ WHEN SHE TRIED TO MOVE THE MONITOR ARM LOWER THE WHOLE THING LET GO, HIT HER ON THE HEAD AND THEN ROLLED OFF HER ARM AND UNTO THE FLOOR. ALTHOUGH THE MONITOR HIT THE NURSE ON THE HEAD, THERE WAS NO PATIENT OR USER HARM REPORTED.

    Description of Event or Problem · 1

    THE NURSE WAS USING THE HANDLE ON THE MOUNTING ARM TO ADJUST THE HEIGHT OF THE MONITOR AND IT BROKE OFF, CAUSING THE MONITOR TO FALL AND HIT THE NURSE ON THE HEAD. THE MX700 MONITOR WITH THE SERIAL NUMBER (B)(4) WAS MOUNTED ON THE M1180A MOUNT. THE NURSE WAS DOING A CAR SEAT TEST ON A BABY IN THE NICU -WHEN SHE TRIED TO MOVE THE MONITOR ARM LOWER THE WHOLE THING LET GO, HIT HER ON THE HEAD AND THEN ROLLED OFF HER ARM AND UNTO THE FLOOR. ALTHOUGH THE MONITOR HIT THE NURSE ON THE HEAD, THERE WAS NO PATIENT OR USER HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    405403 INTELLIVUE MX700 PATIENT MONITOR PATIENT MONITOR MHX PHILIPS MEDICAL SYSTEMS 865241

    Patients

    Seq Age Sex Outcome Treatment
    1