BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOFLOW FILTER PORT

    MDR report key: 1525486 · Received October 27, 2009

    Report

    Report Number
    1525486
    Event Type
    Malfunction
    Date Received
    October 27, 2009
    Date of Event
    October 24, 2009
    Report Date
    October 27, 2009
    Manufacturer
    ARC MEDICAL
    Product Code
    BYD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US

    Narratives

    Description of Event or Problem · 1

    PATIENT EXPERIENCED INCREASED WORK BREATHING. RESPIRATORY RATE IN 20'S. PATIENT WENT INTO BRIEF RUN OF V-TACH, THEN RETURNED TO NORMAL SINUS. PATIENT BAGGED DURING EPISODE AND WHEN PATIENT PLACED BACK ON THE VENT THE HEAT MOISTURE EXCHANGER(HME) WAS NOTED TO BE WET. THE PATIENT THEN HAD PROBLEMS BREATHING AGAIN. THE HME WAS REPLACED WITH A NEW ONE AND PATIENT IMMEDIATELY IMPROVED AND WAS COMFORTABLE.

    Description of Event or Problem · 1

    PATIENT EXPERIENCED INCREASED WORK BREATHING. RESPIRATORY RATE IN 20'S. PATIENT WENT INTO BRIEF RUN OF V-TACH, THEN RETURNED TO NORMAL SINUS. PATIENT BAGGED DURING EPISODE AND WHEN PATIENT PLACED BACK ON THE VENT THE HEAT MOISTURE EXCHANGER(HME) WAS NOTED TO BE WET. THE PATIENT THEN HAD PROBLEMS BREATHING AGAIN. THE HME WAS REPLACED WITH A NEW ONE AND PATIENT IMMEDIATELY IMPROVED AND WAS COMFORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERMOFLOW FILTER PORT HEAT MOISTURE EXCHANGER BYD ARC MEDICAL * 090527-50

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR NO OTHER THERAPIES| NO OTHER THERAPIES