BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TUTTNAUER

    MDR report key: 345684 · Received August 2, 2001

    Report

    Report Number
    MW1022561
    Event Type
    Malfunction
    Date Received
    August 2, 2001
    Date of Event
    January 4, 2001
    Report Date
    August 2, 2001
    Manufacturer
    TUTTNAUER USA CO LTD
    Product Code
    FLE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    DURING A STERILIZATION CYCLE, THE KWIKLAVE AUTOCLAVE EXPLODED. A PIECE OF THE CYLINDER LOCKING MECHANISM BLEW OFF, FLYING ACROSS THE ROOM. THE DOOR FLEW OPEN, FILLING THE IMMEDIATE AREA WITH STEAM. FORTUNATELY, THE STERILIZATION ASSISTANT WAS AWAY FROM THE AREA AT THAT MOMENT. HAD A PT OR STAFF MEMBER BEEN PASSING BY, THEY MAY HAVE BEEN IMPALED BY THE FLYING PROJECTILE OR SCALDED BY THE STEAM RELEASED WHEN THE DOOR BLEW OPEN. SINCE THE AUTOCLAVE WAS PURCHASED IN 1992 IT HAS HAD NUMEROUS PROBLEMS INCLUDING OVERHEATING, BROKEN HEATING ELEMENT, INOPERATIVE ON/OFF SWITCH, DEFECTIVE SAFETY RELEASE VALVE, BROKEN TIMER SWITCH, AND A SEIZED HEATING ELEMENT. THESE PROBLEMS REQUIRED SPENDING $871.17 TO DENTAL SALES REP REPORTS SIMILAR COMPLAINTS FROM OTHER DENTAL CUSTOMERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35134 TUTTNAUER DENTAL AUTOCLAVE FLE TUTTNAUER USA CO LTD 2340 MK *

    Patients

    Seq Age Sex Outcome Treatment
    1 *