BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRAVIEW

    MDR report key: 11588161 · Received March 30, 2021

    Report

    Report Number
    11588161
    Event Type
    Malfunction
    Date Received
    March 30, 2021
    Date of Event
    March 23, 2021
    Report Date
    March 23, 2021
    Manufacturer
    ZOE MEDICAL, INC.
    Product Code
    DXN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    LA
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ON A NEW NEONATE ADMIT, THE CUFF BLOOD PRESSURE (BP) QUIT WORKING AND THE MASSIMO PULSE OX WAS NOT TRANSFERRING TO THE SPACE LABS. AS A RESULT, THE SATS WERE NOT RELAYING TO THE CENTRAL MONITOR. BIOMED HAD TO COME TROUBLESHOOT TO FIX IT. IT REQUIRED SWITCHING OUT THE ENTIRE MASSIMO. NO PATIENT HARM. IN-HOUSE BIOMED FOLLOW UP: SPACELABS MONITOR 90369: CUSTOMER REPORTED BP NOT WORKING AND SPO2 READING NOT TRANSFERRING FROM MASIMO DOCK. RAN FUNCTIONAL BP TESTS, UNSUCCESSFUL. CHANGED BP HOSE AND SUCCESSFULLY PASSED TESTS. SWITCHED MASIMO DOCKS AND WAS UNSUCCESSFUL IN TRANSFERRING READING. SWITCHED SPACELABS MONITORS WITH EMPTY BEDSPACE AND SUCCESSFULLY TRANSFERRED MASIMO SPO2 READING. VERIFIED PROPER OPERATION AND RETURNED TO SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    486919 ULTRAVIEW SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE DXN ZOE MEDICAL, INC. 90369

    Patients

    Seq Age Sex Outcome Treatment
    1