BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AQUA SEAL ATS - CDU

    MDR report key: 181979 · Received August 12, 1998

    Report

    Report Number
    9611018-1998-00013
    Event Type
    Malfunction
    Date Received
    August 12, 1998
    Report Date
    July 13, 1998
    Manufacturer
    SHERWOOD MEDICAL INDUSTRIES
    Product Code
    KDQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTS, THE FLOW CONTROL VALVE ON THE AQUA SEAL CDU WILL NOT COMPLETELY SHUT OFF THE SUCTION TO THE CDU. THE VALVE WILL ONLY DECREASE THE FLOW OF AIR WHEN IN THE FULLY CLOSED POSITION. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AQUA SEAL ATS - CDU CHEST DRAINAGE UNIT WITH AUTO TRANSFUSION KDQ SHERWOOD MEDICAL INDUSTRIES NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN