BEUDAMED
    FDA Adverse Event Death Summary report: N

    ULTRAVIEW DM3

    MDR report key: 5766357 · Received July 1, 2016

    Report

    Report Number
    3003294644-2016-00001
    Event Type
    Death
    Date Received
    July 1, 2016
    Date of Event
    April 13, 2016
    Report Date
    May 2, 2016
    Manufacturer
    ZOE MEDICAL, INCORPORATED
    Product Code
    DXN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    (B)(4) REPORTS THAT THE DM3 MONITOR (91330) FAILED TO ALARM FOR LOW NIBP ON PATIENT THAT CODED. PATIENT ADMIT FOR CEREBRAL INFARCTION AND HEART DISEASE. PATIENT HAD MULTIPLE STENTS. NEW STENT @ (B)(6) ON (B)(6) 2016. ADMIT TO (B)(6) 2016 AT 02:30. PATIENT CODE ON (B)(6) 2016 APPROX. 09:10 IN NEURO UNIT ON DM3. PATIENT CODE ON (B)(6) 2016 APPROX. 10:34 IN ICU. PATIENT PASSED ON (B)(6) 2016 AT 15:20. HOSP. RISK MANAGER STILL COLLECTING DATA. DM3 WAS REMOVED FROM PATIENT ROOM BY (B)(4) AT REQUEST OF NURSING FOR TESTING. MONITOR WAS TURNED OFF AND DEFAULTED BACK TO SPOT MODE. (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418616 ULTRAVIEW DM3 PATIENT MONITOR DXN ZOE MEDICAL, INCORPORATED 91330

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death