BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYSTEM 83+2

    MDR report key: 842126 · Received April 27, 2007

    Report

    Report Number
    2523209-2007-00013
    Event Type
    Injury
    Date Received
    April 27, 2007
    Date of Event
    March 16, 2004
    Report Date
    April 26, 2007
    Manufacturer
    CUSTOM ULTRASONICS, INC.
    Product Code
    FEB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON INVESTIGATION, IT WAS DETERMINED THAT THE SYSTEM WAS OPERATING ACCORDING TO SPECIFICATIONS. HOWEVER, WHEN ASKED TO DEMONSTRATE THE PROPER PROCEDURE FOR USING THE SYSTEM 83, THE DEVICE USER COULD NOT DO SO AND EMPLOYED A TECHNIQUE THAT WOULD NOT RESULT IN THE PROPER CLEANING OF THE DEVICE. CU HAS RECORDS INDICATING THAT THE DEVICE USERS AT THIS FACILITY HAD PREVIOUSLY REC'D TRAINING FROM CU ON THE PROPER METHODS TO USE THE SYSTEM 83. THE USER THAT WAS USING THE DEVICE IMPROPERLY HAD NOT REC'D TRAINING FROM CU AND WAS NOT PROPERLY TRAINED BY THE FACILITY. TO PREVENT FUTURE OCCURRENCES OF THE PROBLEM, CU RETRAINED THE FACILITY'S STAFF ON THE PROPER PROCEDURES FOR DEVICE USE AND PREVENTATIVE MAINTENANCE.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED A POSSIBLE PROBLEM WITH THE FUNCTIONING OF THEIR SYSTEM 83 THAT MAY HAVE RESULTED IN THE TRANSMISSION OF HEPATITIS C TO A PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYSTEM 83+2 ULTRASONIC MEDICAL EQUIPMENT CLEANER FEB CUSTOM ULTRASONICS, INC. 83+2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Other