BEUDAMED
    FDA Adverse Event Other Summary report: N

    CUSTOM ULTRASONICS SYSTEM 83 PLUS

    MDR report key: 980635 · Received December 30, 2005

    Report

    Report Number
    2523209-2004-00005
    Event Type
    Other
    Date Received
    December 30, 2005
    Date of Event
    February 4, 2004
    Report Date
    September 29, 2004
    Manufacturer
    CUSTOM ULTRASONICS INC.
    Product Code
    FLG
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    HOSP STATES O-RINGS WERE SWOLLEN. HOSP STATES THEY WERE USING TERGAL 800 AS A DETERGENT BUT RECORDS INDICATE OTHERWISE. (CU TECH) WAS SENT TO THE FACILITY TO CHECK THE SYSTEMS AND FOUND THAT ALL SYSTEMS (5 TOTAL BAYS) WHERE OPERATIONAL TO FACTORY SPECS. CU TECH DID NOTICE IMPROPER CONNECTIONS TO THE SCOPE BY THE OPERATOR OF THE SYSTEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CUSTOM ULTRASONICS SYSTEM 83 PLUS WASHER DISINFECTOR FLG CUSTOM ULTRASONICS INC. 83+2CI *

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other