BEUDAMED
    FDA Adverse Event Summary report: N

    ULTRAVIEW

    MDR report key: 8439304 · Received March 21, 2019

    Report

    Report Number
    8439304
    Date Received
    March 21, 2019
    Date of Event
    March 7, 2019
    Report Date
    March 11, 2019
    Manufacturer
    SPACELABS HEALTHCARE (WASHINGTON), INC
    Product Code
    MHX
    Report Source
    User Facility report
    Reporter Location
    LA
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE BEDSIDE CARDIAC MONITOR WAS WORKING WHEN WE ARRIVED IN THE ROOM, BUT SHORTLY THEREAFTER THE BEDSIDE CARDIAC MONITOR DID NOT. WE ALL ATTEMPTED TO TROUBLESHOOT IT, BUT IT WOULD NOT WORK. WE HAD TO GET A PORTABLE MONITOR TO GET THE PATIENTS INFO UP. WE THEN MOVED HIM TO AN OPEN ROOM. SPACELABS CPU: LAST PM 11/2017. NEXT PM 11/2019. ORDERED PART DAY REPORTED. BACKPLANE BOARD. PART#: 670-0915-03.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232444 ULTRAVIEW MONITOR, PHYSIOLOGICAL, PATIENT (WITH ARRHYTHMIA DETECTION OR ALARMS) MHX SPACELABS HEALTHCARE (WASHINGTON), INC

    Patients

    Seq Age Sex Outcome Treatment
    1