BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSURGICAL

    MDR report key: 7507805 · Received May 11, 2018

    Report

    Report Number
    1319447-2018-00004
    Event Type
    Malfunction
    Date Received
    May 11, 2018
    Report Date
    May 11, 2018
    Manufacturer
    INTERSURGICAL INC
    Product Code
    BZE
    PMA / PMN Number
    K092129
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN INSPECTION OF THE DEVICE INVOLVED IN THIS COMPLAINT COULD NOT BE CONDUCTED SINCE THE DEVICE WAS NOT RETURNED. THE DEVICE SAMPLE IS NECESSARY TO PERFORM THE PRODUCT INVESTIGATION. CUSTOMER COMPLAINT CANNOT BE CONFIRMED BASED ONLY ON THE INFORMATION PROVIDED. IF THE DEVICE SAMPLE BECOMES AVAILABLE AT A LATER DATE THIS COMPLAINT WILL BE UPDATED. DURING MANUFACTURE OF THE 2026030 H/W SYSTEMS THEY ARE BEING 3 TIMES 100% CONNECTED AND LATER DISCONNECTED FROM 5601000 ELECTRICAL ADAPTOR LEAD FOR VARIOUS TESTS. THE T-PIECE AND PLUG DIAMETERS ARE CHECKED DURING ROUTINE MOLDING.

    Description of Event or Problem · 1

    THE INNER PLUG OF THE HEAT WIRE CIRCUIT WAS PULLED OUT OF THE PLASTIC ADAPTER HOUSING WHEN DISCONNECTING FROM THE HEATER. THIS MAY REQUIRE MANUAL VENTILATION WHILE A NEW CIRCUIT IS PUT IN PLACE. THERE IS NO PATIENT HARM OR ISSUES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348545 INTERSURGICAL 22MM FLEXTUBE DUAL HEATED WIRE BREATHING SYSTEM BZE INTERSURGICAL INC 2026030

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention