BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TABLE TOP STERILIZER

    MDR report key: 7818699 · Received August 24, 2018

    Report

    Report Number
    MW5079403
    Event Type
    Malfunction
    Date Received
    August 24, 2018
    Date of Event
    August 8, 2018
    Report Date
    August 14, 2018
    Manufacturer
    TUTTNAUER USA CO., LTD
    Product Code
    FLE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    DURING REGULAR CYCLE, THE TABLE TOP STERILIZERS FAILED SAFE. EVALUATION OF THEM SHOWED THAT WATER PUMP IS DEFECTIVE. THE PUMP IS FURNISHED AS PART OF STERILIZERS SHOULD BE USED WITH WATER WHICH HAS MAX TEMPERATURE 25 DEGREE CELSIUS. BUT ACTUAL WATER TEMPERATURE IS GREATER 65 DEGREE CELSIUS. BOTH MODELS OF TOTTNAUER STERILIZERS HAVE SAME PUMPS WHICH DON'T MEET STERILIZERS DESIGN REQUIREMENT. PUMP MODEL IS E, TYPE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    656464 TABLE TOP STERILIZER STERILIZER, STEAM FLE TUTTNAUER USA CO., LTD EZ 11 PLUS
    656465 TABLE TOP STERILIZER STERILIZER, STEAM FLE TUTTNAUER USA CO., LTD 3870EA

    Patients

    Seq Age Sex Outcome Treatment
    1