BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TUTTNAUER AUTOCLAVE

    MDR report key: 245689 · Received August 30, 1999

    Report

    Report Number
    MW4002625
    Event Type
    Malfunction
    Date Received
    August 30, 1999
    Report Date
    August 26, 1999
    Manufacturer
    TUTTNAUER USA CO. LTD.
    Product Code
    FLE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    RPTR HAS A TUTTNAUER AUTOCLAVE, MODEL #2540M. A CAST METAL WASHER THAT HOLDS THE PRESSURE OF THE LOCKING SPINDLE OF THE DOOR FRAGMENTED ALLOWING THE AUTOCLAVE DOOR TO BLOW OPEN. IF A PERSON HAD BEEN STANDING NEAR THE AUTOCLAVE THEY WOULD HAVE BEEN SEVERELY INJURED. SINCE IT IS OBVIOUS THAT THE WASHER HOLDING THE PRESSURE OF THE DOOR WAS MADE OF INFERIOR CAST MATERIAL RATHER THAN STAINLESS STEEL OR ANOTHER SUITABLE MATERIAL, RPTR ASKS WHY THIS COMPANY DID NOT NOTIFY OWNERS OF THESE AUTOCLAVES, OF THE DANGER AND SHIP THEM REPLACEMENT PARTS. ACCORDING TO RPTR, FOR SOME REASON, SURGICAL SUPPLY COMPANIES GO IN AND OUT OF BUSINESS FREQUENTLY. THEREFORE, MANUFACTURERS OF DEFECTIVE EQUIPMENT NOTIFYING SALESPEOPLE IS OBVIOUSLY INADEQUATE. REPORTER FEELS OWNERS OF DEFECTIVE EQUIPMENT SHOULD BE NOTIFIED DIRECTLY BY THE COMPANY AND PUBLICITY OF DEFECTS SHOULD BE MANDATORY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA