BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERILIZER, STEAM

    MDR report key: 6948178 · Received October 13, 2017

    Report

    Report Number
    6948178
    Event Type
    Malfunction
    Date Received
    October 13, 2017
    Date of Event
    August 23, 2017
    Report Date
    September 19, 2017
    Manufacturer
    GETINGE USA, INC.
    Product Code
    FLE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PER THE GETINGE REP REPORT: "CUSTOMER IS GETTING INTERMITTENT FAILED BIO'S ON THEIR INCUBATOR. THE FAILURES OCCUR MAINLY ON THE FIRST CYCLE OF THE DAY AND WHEN USING WELL #2 IN THE 3M INCUBATOR. ONE FAILURE OCCURRED IN WELL #7 BUT THAT VIAL DID CHANGE TO THE CORRECT COLOR OF A NEGATIVE TEST. I CHECKED THE COMPONENTS OF THE STERILIZER BUT DID NOT FIND ANY PROBLEMS OTHER THAN SOME WEAR ON THE DOOR GASKET WHICH I REPLACED. I RAN A LEAK TEST. THE UNIT PULLED A VACUUM DOWN TO .30PSI. THE GOAL IS LESS THAN 1PSI. THE CYCLE FINISHED AT .31PSI, LOSING .01PSI. THE GOAL IS TO LOSE LESS THAN .75PSI . THE GETINGE CONSUMABLE REP IS BRINGING IN BIOLOGICAL TEST PACKS AND AN INCUBATOR TO RUN TESTS ALONG WITH THE CURRENT PRODUCT. THE CUSTOMER WILL ALSO USE DIFFERENT WELLS IN THEIR INCUBATOR TO RULE OUT WELL #2. MANUFACTURER RESPONSE FOR BIOLOGICAL CONTROL INCUBATOR, 3M ATTEST RAPID 5 (PER SITE REPORTER). THE GETINGE CONSUMABLE REP IS BRINGING IN BIOLOGICAL TEST PACKS AND AN INCUBATOR TO RUN TESTS ALONG WITH THE CURRENT PRODUCT TO VERIFY THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    728157 STERILIZER, STEAM FLE GETINGE USA, INC. 633HC

    Patients

    Seq Age Sex Outcome Treatment
    1