BEUDAMED
    FDA Adverse Event Summary report: N

    MERGE HEMO (FORMERLY VERICIS)

    MDR report key: 3657448 · Received February 27, 2014

    Report

    Report Number
    3657448
    Date Received
    February 27, 2014
    Date of Event
    February 21, 2014
    Report Date
    February 27, 2014
    Manufacturer
    MERGE HEALTHCARE INC. (FORMERLY CAMTRONICS)
    Product Code
    DQK
    Report Source
    User Facility report
    Reporter Location
    SC, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE MERGE HEMODYNAMIC RECORDING SYSTEM IS OUR PRIMARY MODE OF MONITORING O2 SAT WHILE PERFORMING MODERATE SEDATION. DURING THE PROCEDURE, IT WAS NOTED THAT THE O2 SAT WAS STAYING AT 98% AND NOT CHANGING. THE WAVEFORM AND PULSE DISPLAY INDICATED THAT THE SENSOR WAS WORKING APPROPRIATELY HOWEVER THE O2 VALUE WAS FROZEN. WHEN THIS WAS NOTICED A SECONDARY O2 SENSOR WAS PLACED AND THE O2 SAT WAS FOUND TO BE IN THE 89-90% RANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    122378 MERGE HEMO (FORMERLY VERICIS) COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK MERGE HEALTHCARE INC. (FORMERLY CAMTRONICS) * *

    Patients

    Seq Age Sex Outcome Treatment
    1 * NO OTHER THERAPIES