BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BEMIS 1200CC HIFLOW SUCTION CANISTER

    MDR report key: 1427721 · Received April 6, 2009

    Report

    Report Number
    2133713-2009-00003
    Event Type
    Malfunction
    Date Received
    April 6, 2009
    Date of Event
    March 25, 2009
    Report Date
    April 3, 2009
    Manufacturer
    BEMIS MFG. CO.
    Product Code
    KDQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED WAS DISPOSED OF AND NO LONGER AVAILABLE FOR ANALYSIS. COMPLAINANT DID NOT KNOW IF COVER OR CANISTER IMPLODED. COMPLAINANT HAD ANOTHER DEVICE MODEL 7H480410 AVAILABLE WITH SERIAL NUMBER (B)(4). THAT SERIAL NUMBER CORRESPONDS TO JUNE 2004 DATE OF PRODUCTION. CUSTOMER WAS ADVISED THAT PRODUCT HAS AN EXPIRATION DATE AS OF 2007, AND THAT WE RECOMMEND REPLACING CANISTER ON CRASH CART WHEN ANNUAL PM IS PERFORMED. WE SUSPECT BUT CANNOT PROVE THAT THE CANISTER WAS ON CRASH CART SINCE 2004, AND CONSEQUENTLY WAS WEAKENED DUE TO EXCESSIVE UV EXPOSURE OVER 5 YEARS.

    Description of Event or Problem · 1

    COMPLAINANT STATED THAT A CANISTER USED ON A CRASH CART IMPLODED WHEN USED DURING A CODE. COMPLAINANT DECLINED TO SAY WHAT IF ANY PT CONSEQUENCES RESULTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BEMIS 1200CC HIFLOW SUCTION CANISTER APPARATUS, SUCTION, VACUUM POWERED KDQ BEMIS MFG. CO. 484410 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1