BEUDAMED
    FDA Adverse Event Other Summary report: N

    CUSTOM ULTRASONICS SYSTEMS 83 PLUS

    MDR report key: 980242 · Received December 30, 2005

    Report

    Report Number
    2523209-2004-00003
    Event Type
    Other
    Date Received
    December 30, 2005
    Date of Event
    December 9, 2003
    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 THE WERE USING TERGAL 800 AS A DETERGENT BUT RECORDS INDICATE OTHERWISE. (CU TECH) WAS SENT TO THE FACILITY TO CHECK THE SYS AND FOUND THAT ALL SYS (5 TOTAL BAYS) WERE OPERATIONAL TO FACTORY SPECS. CU TECH DID NOTICE IMPROPER CONNECTIONS TO THE SCOPE BY THE OPERATOR OF THE SYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CUSTOM ULTRASONICS SYSTEMS 83 PLUS WASHER DISINFECTOR FLG CUSTOM ULTRASONICS, INC 83-21CI *

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other