BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BEMIS 1200CC HI-FLOW SUCTION CANISTER

    MDR report key: 3940764 · Received April 22, 2014

    Report

    Report Number
    2133713-2014-00010
    Event Type
    Malfunction
    Date Received
    April 22, 2014
    Date of Event
    March 24, 2014
    Report Date
    April 22, 2014
    Manufacturer
    BEMIS MFG. CO.
    Product Code
    GCX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONTINUING TO CONTACT THE USER TO ACQUIRE MORE DETAILED INFO. WILL UPDATE REPORT IF ADDITIONAL DETAILS ARE REQUIRED.

    Description of Event or Problem · 1

    COMPLAINANT STATES THAT FLOAT VALVE IN SUCTION CANISTER IS SHUTTING OFF PREMATURELY CAUSING THE CANISTER TO LOSE SUCTION IN THE OPERATING ROOM

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242658 BEMIS 1200CC HI-FLOW SUCTION CANISTER APPARATUS, SECTION, VACUUM POWERED GCX BEMIS MFG. CO. 484410 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1