BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUCTION RESERVOIR 400CC LG VOL

    MDR report key: 914750 · Received October 7, 2004

    Report

    Report Number
    1423507-2004-00094
    Event Type
    Malfunction
    Date Received
    October 7, 2004
    Date of Event
    July 26, 2004
    Report Date
    October 6, 2004
    Manufacturer
    CARDINAL HEALTH
    Product Code
    GCY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH CARDINAL HEALTH INITIALLY WAS NOTIFIED OF THIS INCIDENT ON 08/02/04, IT WAS NOT UNTIL 09/13/04 THAT CARDINAL HEALTH RECEIVED SUFFICIENT INFORMATION FROM THE END USER TO DETERMINE WHETHER THIS WAS A REPORTABLE EVENT. THE PRODUCT SAMPLE WAS RECEIVED FOR EVALUATION ON 09/07/04. IT WAS OBSERVED THAT THE HELMET WAS DETACHED FROM THE BODY OF RESERVOIR MAKING THE DEVICE NON-FUNCTIONAL. THE PROBLEM WAS FOUND TO BE RELATED TO THE DUROMETER OF THE RESERVOIR MATERIAL. THE DUROMETER WAS CHANGED FROM 40 TO 50 AND THE CHANGE IMPLEMENTED ON MARCH 15, 2004. DUROMETER IS A VALUE THAT MEASURES THE HARDNESS OF THE SILICONE MATERIAL. THIS ENHANCEMENT CAUSES THE MATERIAL TO BECOME HARDER, THEREFORE RESULTING IN A MORE ADEQUATE PRESSURE SEAL BETWEEN THE HELMET, COLLAR AND BODY OF THE PRODUCT. AFTER THIS MODIFICATION, AN ASSESSMENT WAS PERFORMED TO VERIFY ITS EFFECTIVENESS. ALL UNITS TESTED PASSED THE SUCTION, LEAK AND ACTIVATION TESTS. THE FIRST LOT WITH THE 50 DUROMETER AS SU130-1000 WITH LOT NUMBER 1040237. THE LOT REPORTED IN THIS INCIDENT WAS MANUFACTURED PRIOR TO THIS CHANGE. IN ADDITION TO THIS CHANGE, PERSONNEL WERE RETRAINED FOR THEIR AWARENESS.

    Description of Event or Problem · 1

    PRODUCT HAD A LOSS OF VACUUM WHICH CAUSED TROUBLE FOR THE PATIENT, I.E., THE PHYSICIAN HAD TO MANUALLY SUCTION WITH A SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUCTION RESERVOIR 400CC LG VOL SUCTION RESERVOIR GCY CARDINAL HEALTH SU130-1000 1030064

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other