BEUDAMED
    FDA Adverse Event Other Summary report: N

    CUSTOM ULTRASONICS, INC.

    MDR report key: 1169640 · Received September 18, 2008

    Report

    Report Number
    2523209-2008-00003
    Event Type
    Other
    Date Received
    September 18, 2008
    Date of Event
    August 25, 2008
    Report Date
    September 18, 2008
    Manufacturer
    CUSTOM ULTRASONICS INC.
    Product Code
    FLG
    PMA / PMN Number
    K983017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    TECHNICIAN DISPATCHED TO USER FACILITY IN (B) (6) TO EVALUATE THIS DEVICE. OLDER SYSTEM SUBJECT TO F6 KEY COVER INSTALLATION AS PART OF ONGOING CAMPAIGN TO FURTHER ELIMINATE CHANCES FOR USER ERROR/CONFUSION DUE TO LACK OF PERSONNEL TRAINING. SYSTEM 83+2 DEVICE WAS RETESTED AND FOUND TO BE IN PERFECT WORKING ORDER. ABOUT 17 "WASH ONLY" CYCLES WERE CONFIRMED BY RECORDED DATA BASE INFORMATION STORED BY DEVICE COMPUTER. RECORDED USER WAS NEVER FORMALLY TRAINED BUT HAD HISTORY OF PROPERLY USING THE DEVICE WHICH IS DOCUMENTED. RE-TRAINING WAS CONDUCTED WITH ALL HOSPITAL STAFF AND PREVIOUSLY TRAINED STAFF AUTHORIZED TO USE THE DEVICE. HOSPITAL CONTACT EXPLAINED THAT ALL PATIENT WILL BE NOTIFIED BY THE FACILITY OF POSSIBLE INFECTION RISK.

    Description of Event or Problem · 1

    USER FACILITY REPRESENTATIVE REPORTED THAT A STAFF MEMBER USED THE SYSTEM 83+2 WASHER/DISINFECTOR INCONSISTENTLY WITH USER INSTRUCTIONS RESULTING IN USER ERROR AND POSSIBILITY FOR INFECTION IN 17 CASES. UNTRAINED USER SELECTED "WASH ONLY" CYCLE WHEN "WASH AND DISINFECT" WAS RECOMMENDED. USER WAS NOT PRESENT AT INITIAL ON-SITE TRAINING SESSION CONDUCTED AND DOCUMENTED ON 10/30/2007. USER IS DOCUMENTED ON SYSTEM LOG DATA BASE AS HAVING PERFORMED 4 "WASH AND DISINFECT" CYCLES PRIOR TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CUSTOM ULTRASONICS, INC. SYSTEM 83+2 WASHER DISINFECTOR FLG CUSTOM ULTRASONICS INC. SYSTEM 83+2 EQ#3057

    Patients

    Seq Age Sex Outcome Treatment
    1 Other