BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERISIL G5

    MDR report key: 18419235 · Received December 28, 2023

    Report

    Report Number
    MW5149674
    Event Type
    Malfunction
    Date Received
    December 28, 2023
    Date of Event
    December 26, 2023
    Report Date
    December 26, 2023
    Manufacturer
    SOLMETEX (STERISIL)
    Product Code
    EIA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    A WATER FILTRATION UNIT FAILED MULTIPLE TIMES DUE TO A KNOWN FAULTY FLOWMETER, FLOODING OUR STERILE PROCESSING DEPARTMENT CAUSING STERILIZATION TO BE HALTED AND IMPACTING OUR ABILITY TO FACILITATE PATIENT CARE. PART WAS REPLACED RECENTLY DUE TO SAME PROBLEM. MANUFACTURER TECH SUPPORT LISTED PART AS A COMMON POINT OF FAILURE. FLOWMETER IS IDENTIFIED AS PART #10 ON UNIT SCHEMATICS ATTACHED NEAR THE BLADDER TANK. SPECIFICALLY THE FLOWMETER FAILS ORTHOGONALLY TO THE PART AS IT EXPLODES DUE TO OVER PRESSURE FOR THE MATERIAL. CLEARLY A CASE OF BAD MANUFACTURING THAT WILL CONTINUE TO CAUSE PROBLEMS THAT WILL IMPACT PATIENT CARE OPERATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2106515 STERISIL G5 UNIT, OPERATIVE DENTAL EIA SOLMETEX (STERISIL) G5

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown