BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM 83 PLUS 2

    MDR report key: 4987918 · Received August 10, 2015

    Report

    Report Number
    3007082252-2015-00001
    Event Type
    Malfunction
    Date Received
    August 10, 2015
    Date of Event
    October 23, 2014
    Report Date
    January 28, 2015
    Manufacturer
    CUSTOM ULTRASONICS INC.
    Product Code
    FEB
    PMA / PMN Number
    K983017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WERE NO REPORTED INJURIES ASSOCIATED WITH THS EVENT. WHILE CONDUCTING THE QUARTERLY PREVENTATIVE MAINTENANCE, THE THIRD PARTY SERVICE REPRESENTATIVE WAS FUNCTIONALLY CHECKING THE SYSTEM AND IT WAS NOTED THAT THE ULTRASONICS WERE NOT FUNCTIONING. THE SERVICE TECHNICIAN DID NOT REPORT THIS INCIDENT TO CUSTOM ULTRASONICS UNTIL (B)(6) 2015. THE REPORTED SYMPTOM WAS ATTRIBUTED TO A FAILED SOLDER CONNECTION TO THE NEUTRAL CONNECTION OF THE 24 PIN CONNECTOR INSIDE THE RELAY BOX, WHERE IT IS SOLDERED INTO A COMMON NEUTRAL OR GROUND BUSS THERE HAD BEEN A BROKEN SOLDER CONNECTION AND WAS NOT COMPLETING THE CIRCUIT FOR THE UT GENERATOR BOARD AND THUS CAUSING IT TO BE INOPERABLE. THE AUTHORIZED THIRD PARTY SERVICE TECHNICIAN RE-SOLDERED THE CONNECTION ON THE BACK SIDE OF THE 24 PIN CONNECTOR LOCATED INSIDE THE RELAY BOX, THEN VERIFIED CONTINUITY OF THE CIRCUIT, OPERATIONALLY TESTED THE UT GENERATOR BOARD AND FINALLY OPERATIONALLY TESTED THE MACHINE (SEE PRINTOUT FOR PROCESS (B)(4)). 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. 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 BIO BURDEN 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

    DURING PREVENTIVE MAINTENANCE, THE SERVICE TECHNICIAN NOTICED THAT THE ULTRASONIC FUNCTION WAS NOT WORKING. THE SERVICE TECHNICIAN DID NOT NOTIFY CUSTOM ULTRASONICS OF THIS EVENT UNTIL (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    522220 SYSTEM 83 PLUS 2 ENDOSCOPE WASHER-DISINFECTOR FEB CUSTOM ULTRASONICS INC.

    Patients

    Seq Age Sex Outcome Treatment
    1