BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TD 100

    MDR report key: 6456341 · Received April 4, 2017

    Report

    Report Number
    6456341
    Event Type
    Malfunction
    Date Received
    April 4, 2017
    Date of Event
    March 2, 2017
    Report Date
    March 7, 2017
    Manufacturer
    CS MEDICAL, LLC
    Product Code
    ITX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    HOSPITAL WAS UNDER A BOIL WATER ADVISORY AND IN THEIR REVIEW OF PROCESSES FOUND: THE TD-100 IS AN AUTOMATED REPROCESSOR SPECIFICALLY FOR TEE PROBES. IT ACHIEVES CHEMICAL HIGH-LEVEL DISINFECTION. CURRENTLY THERE IS AN OPTIONAL BACTERIAL FILTER (0.2 MICRON.) HOSPITAL FEELS THAT MANUFACTURER SHOULD ENSURE FILTERS ARE SOLD WITH THE TD-100'S. THERE SHOULDN'T BE AN OPTION TO PURCHASE WITHOUT THE FILTER. THE STANDARD FOR AUTOMATED ENDOSCOPE REPROCESSOR'S STATES: ANSI/AAMI ST91:2015 FLEXIBLE AND SEMI-RIGID ENDOSCOPE PROCESSING IN HEALTH CARE FACILITIES. "THE MICROBIAL QUALITY OF THE RINSE WATER WILL VARY AND MAY RECONTAMINATE THE PROCESSED DEVICE (AAMI TIR34). TO AVOID RECONTAMINATING THE DEVICE WITH THE RINSE WATER, THE INCOMING AUTOMATED ENDOSCOPE REPROCESSOR (AER) WATER SHOULD BE AT LEAST FILTERED USING BACTERIAL RETENTIVE FILTERS AS RECOMMENDED IN THE AER MANUFACTURER'S WRITTEN IFU." THIS IS VERY SIMILAR TO THE TEE PROCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238287 TD 100 TRANSDUCER, ULTRASONIC, DIAGNOSTIC ITX CS MEDICAL, LLC TD 100

    Patients

    Seq Age Sex Outcome Treatment
    1