BEUDAMED
    FDA Adverse Event Other Summary report: N

    CUSTOM ULTRASONICS 83PLUS

    MDR report key: 1349346 · Received December 20, 2006

    Report

    Report Number
    2523209-2006-00002
    Event Type
    Other
    Date Received
    December 20, 2006
    Report Date
    December 18, 2006
    Manufacturer
    CUSTOM ULTRASONICS INC
    Product Code
    FLG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    HOSPITAL SHOULD RETRAIN STAFF/OPERATOR, TECH STAR WILL BE NOTIFIED TO OVERSEE IN-SERVICE, PRINTOUT SHOULD BE UTILIZED AND CHECKED AFTER EACH RUN FOR ERRORS.

    Description of Event or Problem · 1

    STAFF/OPERATOR(S) PRESSING WASH ONLY KEY THERE BY ONLY WASHING AND RINSING SCOPE. STAFF/OPERATORS SHOULD PRESS WASH/DISINFECT KEY SO THAT UNIT CYCLES AS WASH/RINSE/DISINFECT/RINSE/RINSE/RINSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CUSTOM ULTRASONICS 83PLUS 83 PLUS FLG CUSTOM ULTRASONICS INC 83 PLUS 2

    Patients

    Seq Age Sex Outcome Treatment
    1