BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM 83 PLUS 2

    MDR report key: 4988653 · Received August 10, 2015

    Report

    Report Number
    3007082252-2014-00031
    Event Type
    Malfunction
    Date Received
    August 10, 2015
    Date of Event
    November 14, 2014
    Report Date
    September 4, 2015
    Manufacturer
    CUSTOM ULTRASONICS INC.
    Product Code
    FEB
    PMA / PMN Number
    K983017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HOSPITAL SERVICE TECHNICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THERE ARE NO INJURIES ASSOCIATED WITH THIS EVENT. EVALUATION SUMMARY: THE REPORTED SYMPTOM, IN REGARDS TO THE WATER CHANNEL ERROR, WAS ATTRIBUTED TO A FAILED FLOJET PURGE PUMP (2100-5-15A), DATE CODE JULY 2013, P/N 11010, AND WAS CAUSED BY THERMAL DAMAGE WHICH LEAD TO PREMATURE FAILURE OF THE PUMP. THE REPORTED SYMPTOM RELATING TO THE ULTRASONICS NOT PERFORMING AS INTENDED WAS ATTRIBUTED TO THE ULTRASONIC GENERATOR (500 W) BOARD ONLY, DATE CODE 2012, P/N 12008, AND WAS CAUSED BY A FAULTY RESISTOR. THE LOSS OF THE ULTRASONIC GENERATOR DOES NOT, OF AND BY ITSELF, RESULT IN AN ENDOSCOPIC HIGH LEVEL DISINFECTION PROCESS FAILURE THAT DOES NOT RENDER A MICROBIOLOGICALLY SAFE PRODUCT OR PRESENT ANY ADDITIONAL RISKS FOR RE-USE GIVEN THE NATURE OF THE PRE-CLEANING LABELING INSTRUCTIONS AND HIGH-LEVEL DISINFECTION. THE BIOMED / FACILITY STAFF WAS PROVIDED A COPY OF THE TECHNICAL BULLETIN - TB-2013-004. THE CUSTOMER WAS ALSO INFORMED THAT THIS PROCEDURE SHOULD BE CARRIED OUT EVERY MORNING PRIOR TO THE PROCESSING OF ANY SCOPES. GIVEN THE NATURE OF ENDOSCOPE PRE-PROCESSING AND HIGH-LEVEL DISINFECTION BASED ON SGNA GUIDELINES, EITHER THE PRESENCE OR ABSENCE OF ULTRASONICS SHOULD STILL RESULT IS AN ENDOSCOPE THAT HAS HAD ITS BIOBURDEN REDUCED TO AN ACCEPTABLE LEVEL. IT IS CONCLUDED THAT THERE IS NO REASONABLE LIKELIHOOD THAT AN ENDOSCOPE PROCESSED IN THE ABSENCE OF THE ULTRASOUND WILL PRESENT ANY ADDITIONAL RISKS.

    Additional Manufacturer Narrative · 1

    (B)(6).

    Description of Event or Problem · 1

    DURING THE PRE-USE FUNCTION TEST, IT WAS NOTICED THAT THE SYSTEM WOULD DISPLAY A WATER CHANNEL ERROR. WHILE AT FACILITY FOR REPAIR OF THE DEVICE, THE SERVICE REPRESENTATIVE DISCOVERED THAT MACHINE THE ULTRASONICS DID NOT FUNCTION AS INTENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    521841 SYSTEM 83 PLUS 2 ENDOSCOPE WASHER-DISINFECTOR FEB CUSTOM ULTRASONICS INC.

    Patients

    Seq Age Sex Outcome Treatment
    1