BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPACT MONITOR DISPLAY

    MDR report key: 1791177 · Received August 2, 2010

    Report

    Report Number
    9610816-2010-00282
    Event Type
    Malfunction
    Date Received
    August 2, 2010
    Report Date
    June 30, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K001664
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THAT NO AUDIBLE ALARMS WERE BEING PROVIDED AFTER THE DEVICE WAS POWERED ON AND IN USE FOR ABOUT 2 HOURS. PHILIPS IS IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION CONCERNING THIS EVENT AND THE COMPLAINT IS STILL UNDER INVESTIGATION. A FINAL REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETED. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT NO AUDIBLE ALARMS WERE BEING PROVIDED AFTER THE DEVICE WAS POWERED ON AND IN USE FOR ABOUT 2 HOURS.

    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