BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROSTREAM

    MDR report key: 7929348 · Received October 3, 2018

    Report

    Report Number
    7929348
    Event Type
    Malfunction
    Date Received
    October 3, 2018
    Date of Event
    September 21, 2018
    Report Date
    September 27, 2018
    Manufacturer
    ORIDION MEDICAL 1987 LTD.
    Product Code
    CCK
    UDI-DI
    10884521551978
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT DEVELOPED HOSPITAL ACQUIRED PRESSURE INJURY TO LEFT EAR. MAY HAVE BEEN FROM THE END TIDAL CO2 MONITORING (PATIENT CONTROLLED ANALGESIA (PCA) TUBING. THE TUBING IS HARDER AND LESS FLEXIBLE THAN THE REGULAR OXYGEN TUBING THAT WE USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    772674 MICROSTREAM ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE CCK ORIDION MEDICAL 1987 LTD. 015183 10884521551978

    Patients

    Seq Age Sex Outcome Treatment
    1 21170 DA Other