BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MP30 INTELLIVUE PATIENT MONITOR

    MDR report key: 2170858 · Received June 22, 2011

    Report

    Report Number
    9610816-2011-00356
    Event Type
    Malfunction
    Date Received
    June 22, 2011
    Report Date
    May 27, 2011
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K030038
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT THE PT MONITOR FELL TO THE GROUND. RISK ANALYSIS - THIS IS BEING CONSIDERED AN UNEXPECTED FALL OF THE DEVICE. THERE IS NO INDICATION OF ANY DEVICE MALFUNCTION THAT COULD CAUSE THE MONITOR TO FALL. HOWEVER, IN AN ABUNDANCE OF CAUTION, WE WILL REPORT THIS INCIDENT AS THE EXACT CIRCUMSTANCES OF THIS FALL IS UNK AND AN UNEXPECTED MONITOR FALL COULD LEAD TO PT INJURY/HARM. NO PT INCIDENT WAS NOTED. PHILIPS IS IN THE PROCESS OF OBTAINING ADD'L INFO CONCERNING THIS EVENT 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 FELL. NO PT HARM WAS REPORTED.

    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