BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPACT MONITOR DISPLAY

    MDR report key: 3222121 · Received July 2, 2013

    Report

    Report Number
    9610816-2013-00145
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Report Date
    June 10, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K001664
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE CURVES AND ANALOG TURNS OFF, AND NO ALARM OCCURS ON THE MONITOR OR AT THE CONTROL CENTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300537 COMPACT MONITOR DISPLAY MHX, DRT MHX PHILIPS MEDICAL SYSTEMS M3046A

    Patients

    Seq Age Sex Outcome Treatment
    1