BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIVUE MP2

    MDR report key: 2243782 · Received July 29, 2011

    Report

    Report Number
    9610816-2011-00446
    Event Type
    Malfunction
    Date Received
    July 29, 2011
    Report Date
    July 8, 2011
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K040357
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT THIS INTELLIVUE X2 DEVICE SUFFERED A FALL, AND AS A RESULT OF THE DROP, THE HOUSING WAS BROKEN. NO PT HARM WAS REPORTED. THE AVAILABLE INFO DOES NOT SUPPORT THAT THERE WAS A MALFUNCTION OF THE DEVICE BUT IT ALSO DOES NOT IDENTIFY A USER MISUNDERSTANDING/MISUSE AS THE CAUSE OF THIS REPORTED FAILURE TO FUNCTION AS EXPECTED. THERE WAS NO MENTION OF A DEFECTIVE MOUNTING SOLUTION, OR ANY OTHER MECHANICAL DEFECT CONTRIBUTING TO THE DROP, WAS REPORTED. IT WAS NOT REPORTED THAT THIS WAS AN UNEXPECTED DROP. PHILIPS IS IN THE PROCESS OF OBTAINING ADDITIONAL 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 THIS INTELLIVUE X2 DEVICE SUFFERED A FALL, AND AS A RESULT OF THE DROP, THE HOUSING WAS BROKEN. NO PT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTELLIVUE MP2 MHX PHILIPS MEDICAL SYSTEMS M8102A

    Patients

    Seq Age Sex Outcome Treatment
    1