BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOCLAVE

    MDR report key: 31457 · Received March 19, 1996

    Report

    Report Number
    2435367-1996-00001
    Event Type
    Malfunction
    Date Received
    March 19, 1996
    Date of Event
    December 11, 1995
    Report Date
    March 14, 1996
    Manufacturer
    TUTTNAUER CO., LTD.
    Product Code
    FLE
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    THE DOOR LATCH ON A AUTOCLAVE MALFUNCTIONED, CAUSING THE DOOR TO OPEN APPROX 1/4 INCH, RELEASING STEAM AND WATER. THERE WERE NO INJURIES CAUSED BY THIS MALFUNCTION. THE MALFUNCTION WAS CAUSED BY CRACKING OF THE BEARING ASSEMBLY DUE TO OVERTIGHTENING OF THE DOOR. CO HAS HAD ONLY ONE OTHER REPORT OF AN INCIDENT SIMILAR TO THIS OUT OF THE THOUSANDS OF UNITS SOLD. IN BOTH CASES, THE SAFETY LATCH FUNCTIONED PROPERY PREVENTING THE DOOR FROM OPENING MORE THAN 1/4 INCH.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN