BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOCLAVE STERILIZER

    MDR report key: 33231 · Received May 24, 1996

    Report

    Report Number
    MW4001330
    Event Type
    Malfunction
    Date Received
    May 24, 1996
    Date of Event
    December 11, 1995
    Report Date
    December 28, 1995
    Manufacturer
    TUTTNAUER USA CO, LTD.
    Product Code
    FLE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DENTAL CALLED MEDICAL MAINTENANCE TO REPORT THAT AN AUTOCLAVE (STEAM), EXPLODED. INVESTIGATION DONE. A DR AND A TECH WHO ARRIVED AT THE SCENE FIRST, SAID THEY HEARD A LOUD NOISE AND RAN DOWN TO THE ROOM TO FIND THE DOOR SLIGHTLY OPEN WITH WATER COMING FROM THE BOTTOM OF THE UNIT. MAINTENANCE FOUND FRAGMENTS SCATTERED AROUND THE ROOM AND LATER DISCOVERED TO BE PIECES OF THE BEARING ASSEMBLY. FURTHER INVESTIGATION FOUND THAT THE BEARING ASSEMBLY CRACKED WHILE THE UNIT WAS UNDER PRESSURE, LEAVING A GAP ABOUT A 1/4" BETWEEN THE DOOR AND WHERE THE BEARING ASSEMBLY PRESSES AGAINST THE DOOR. THIS CAUSED THE DOOR TO OPEN, FRAGMENTS OF THE BEARING ASSEMBLY INTO THE ROOM. A CONVERSATION WITH TECH-SVS AT MFR, INFORMED RPTR THAT THIS PROBLEM IS CAUSED BY OVER TIGHTENING OF THE DOOR ASSEMBLY. THEY HAVE A MODIFICATION KIT FOR THIS MODEL. THE CO HAS BEEN REPLACING THE DOOR ASSEMBLY ONLY IF THE PROBLEM HAS OCCURRED AND REPORTED TO THEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOCLAVE STERILIZER AUTOCLAVE STERILIZER FLE TUTTNAUER USA CO, LTD. 2540E

    Patients

    Seq Age Sex Outcome Treatment
    1 NA