BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM 83 PLUS 9

    MDR report key: 4988656 · Received August 10, 2015

    Report

    Report Number
    3007082252-2014-00033
    Event Type
    Malfunction
    Date Received
    August 10, 2015
    Date of Event
    December 3, 2014
    Report Date
    December 3, 2014
    Manufacturer
    CUSTOM ULTRASONICS INC.
    Product Code
    FEB
    PMA / PMN Number
    K983017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE ARE NO REPORTED INJURIES ASSOCIATED WITH THIS EVENT. INVESTIGATION IN PROGRESS, UPON COMPLETION, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE REPORTED SYMPTOM WAS ATTRIBUTED TO A SHORTED DIODE, ON THE AC INPUT SIGNAL, WITHIN THE BRIDGE RECTIFIER, BRG1, ON THE ULTRASONIC GENERATOR (500 W) BOARD, P/N 12008, CAUSING THE FUSE TO OPEN, RENDERING THE BOARD INOPERABLE. THIS DIODE IS LOCATED ON THE AC INPUT PLUS SIDE OF THE BRIDGE RECTIFIER AND ITS FAILURE IS LIKELY ATTRIBUTED TO AGE (17 YEARS) AND AN OVER VOLTAGE OR OVER CURRENT CONDITION. 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 REUSE 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 (B)(4) 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.

    Description of Event or Problem · 1

    CUSTOMER STATED THE ULTRASONIC FEATURE WAS NOT FUNCTIONING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    522216 SYSTEM 83 PLUS 9 ENDOSCOPE WASHER DISINFECTOR FEB CUSTOM ULTRASONICS INC.

    Patients

    Seq Age Sex Outcome Treatment
    1