BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPACT MONITOR DISPLAY

    MDR report key: 1853770 · Received October 1, 2010

    Report

    Report Number
    9610816-2010-00548
    Event Type
    Malfunction
    Date Received
    October 1, 2010
    Report Date
    July 14, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K001664
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER REPORTED THAT A MONITOR FELL. NO PT HARM WAS REPORTED. THE AVAILABLE INFO SUPPORTS THAT THERE WAS NO MALFUNCTION. PHILIPS IS IN THE PROCESS OF OBTAINING ADDITIONAL 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 A MONITOR FELL. NO PT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPACT MONITOR DISPLAY MHX, DRT MHX PHILIPS MEDICAL SYSTEMS M3046A

    Patients

    Seq Age Sex Outcome Treatment
    1