BEUDAMED
    FDA Adverse Event Death Summary report: N

    COMPACT MONITOR DISPLAY

    MDR report key: 3161838 · Received June 6, 2013

    Report

    Report Number
    9610816-2013-00124
    Event Type
    Death
    Date Received
    June 6, 2013
    Date of Event
    June 2, 2013
    Report Date
    June 4, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K001664
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A F/U REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE NURSE DID NOT HEAR THE ALARMS OF THE MONITOR. A PT DEATH OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251642 COMPACT MONITOR DISPLAY MHX, DRT MHX PHILIPS MEDICAL SYSTEMS M3046A

    Patients

    Seq Age Sex Outcome Treatment
    1 Death