BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIVUE MP5

    MDR report key: 3043418 · Received March 12, 2013

    Report

    Report Number
    9610816-2013-00062
    Event Type
    Malfunction
    Date Received
    March 12, 2013
    Report Date
    March 1, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K091395
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS FOUND TO HAVE DAMAGE TO THE POWER SUPPLY. WE WILL CONSIDER THAT THE DROPPING WAS NOT EXPECTED, THEREFORE, A REPORTABLE EVENT. AT THIS TIME IT IS UNCLEAR WHETHER THERE WAS A MOUNTING HARDWARE MALFUNCTION, OR WHETHER THE DEVICE WAS NOT PROPERLY MOUNTED OR FIXED. THE MONITOR WAS SENT IN FOR BENCH REPAIR DUE TO THE POWER SUPPLY DAMAGE INCURRED FROM THE MONITOR DROP. PHILIPS IS IN THE PROCESS OF OBTAINING ADD'L INFO REGARDING THIS INCIDENT 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 THE MONITOR DROPPED ALTHOUGH BEING FIXED TO A GCX CART. NO PT INCIDENT OR INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104222 INTELLIVUE MP5 MHX PHILIPS MEDICAL SYSTEMS M8105A (865024)

    Patients

    Seq Age Sex Outcome Treatment
    1