BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRESESS

    MDR report key: 1891022 · Received October 26, 2010

    Report

    Report Number
    1891022
    Event Type
    Malfunction
    Date Received
    October 26, 2010
    Date of Event
    October 4, 2010
    Report Date
    October 26, 2010
    Manufacturer
    INVIVO CORPORATION
    Product Code
    MHX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT CAME FROM THE OR WHILE INTUBATED AND UNDER SEDATION TO HAVE MRI NECK DONE. INVIVO MONITOR FAILED TO PROVIDE ENDTIDAL (ETCO2) FOR ANESTHESIOLOGIST AND NURSE, ANESTHETIST. NUMEROUS ATTEMPTS WERE MADE WITH NO RESULTS. WE THEN DECIDED TO USE ANOTHER MRI MONITOR FOR ENDTIDAL READINGS. NOTE THAT ONLY ETCO2 DID NOT WORK PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRESESS MONITOR, PHYSIOLOGICAL, MRI MHX INVIVO CORPORATION 3160 *

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR OTHER