BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPER SET WITH DOUBLE SWIVEL

    MDR report key: 170532 · Received June 1, 1998

    Report

    Report Number
    MW1013895
    Event Type
    Malfunction
    Date Received
    June 1, 1998
    Date of Event
    June 1, 1998
    Report Date
    June 1, 1998
    Manufacturer
    INTERSURGICAL INC.
    Product Code
    BZA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    ME, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Description of Event or Problem · 1

    THE PRODUCT HAS CRACKS WHICH CAN LEAD TO AIR LEAKS. RPTR BELIEVES THE PROBLEM IS DUE TO A POOR MOLDING PROCESS. NO PT WAS INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUPER SET WITH DOUBLE SWIVEL VENTILATOR BREATHING CIRCUIT BZA INTERSURGICAL INC. UNK 980482

    Patients

    Seq Age Sex Outcome Treatment
    1 NA