BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FEATHER-FLEX ADULT ANESTHESIA CIRCUIT

    MDR report key: 4098326 · Received August 28, 2014

    Report

    Report Number
    3003213883-2014-00001
    Event Type
    Malfunction
    Date Received
    August 28, 2014
    Date of Event
    July 7, 2014
    Report Date
    August 6, 2014
    Manufacturer
    BOMIMED INC.
    Product Code
    BSJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CIRCUIT KIT OL-608030-52 IS NOT SOLD TO U.S. CUSTOMERS (ONLY (B)(4) CUSTOMERS). THE FILTER WITHIN THIS KIT IS OL-04750-00. THIS FILTER IS SOLD TO U.S. CUSTOMERS. DEVICE LISTING #D002125, 510 K851070. UPON REQUEST, NO PT INFO WAS PROVIDED BY THE HOSPITAL.

    Description of Event or Problem · 1

    AFTER EXTENDED USE (OVER 4 HOURS), THE FILTER WITHIN THE BREATHING CIRCUIT ASSEMBLY BECAME SATURATED. THIS RESULTED IN INCREASED AIRWAY PRESSURES OVER 40CMH20. WHEN THE FILTER WAS CHANGED, THE AIRWAY PRESSURES DROPPED TO 20CMH20 (A NORMAL LEVEL).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    524127 FEATHER-FLEX ADULT ANESTHESIA CIRCUIT BREATHING CIRCUIT BSJ BOMIMED INC. OL-608030-52 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention FABIUS GS ANESTHESITIC GAS MACHINE