BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM ULTRASONICS INC. SYSTEM 83 PLUS

    MDR report key: 2889177 · Received December 21, 2012

    Report

    Report Number
    2523209-2012-00006
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Date of Event
    November 29, 2012
    Report Date
    December 21, 2012
    Manufacturer
    CUSTOM ULTRASONICS INC
    Product Code
    KOG
    PMA / PMN Number
    K983017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION REVEALED THAT THERE WAS A WASH ONLY CYCLE USED TO PROCESS A SCOPE, EVIDENT FROM THE PRINT OUT RETRIEVED FROM THE CENTER. THE CU TECH REQUESTED THAT THE SCOPE BE QUARANTINED AND RE PROCESSED BUT THE CENTER'S STAFF WAS NOT SURE THE SCOPE COULD BE RETRIEVED. THE CU TECH ALSO NOTED THAT THE SAFETY KEY COVER (WASH ONLY) WAS MISSING. THE SAFETY COVER WAS REPLACED. AT THIS TIME THE (B)(6) COULD NOT RESPOND TO OUR TWO QUESTIONS: CAN YOU PROVIDE CUSTOM ULTRASONICS INC WITH WRITTEN VERIFICATION THAT THE AFOREMENTIONED INSTRUMENTS THAT WERE ONLY "WASHED" WERE QUARANTINED AND KNOWN NOT TO HAVE BEEN USED ON ANY PTS' CAN YOU PROVIDE CUSTOM ULTRASONICS INC WITH WRITTEN VERIFICATION THAT THE SYSTEM 83 PLUS'S DOS-BASED COMPUTER DATABASE DID NOT REPEATEDLY RECORD "WASH-ONLY" CYCLES THROUGHOUT ANY GIVEN DAY DURING THE PAST FEW MONTHS, BUT WERE INSTEAD ROUTINELY FOLLOWED BY A "WASH-DISINFECT" CYCLE? TO DATE CUSTOM ULTRASONICS INC DID NOT RECEIVE F/U TO THESE QUESTIONS, THE MEDICAL CENTER'S INVESTIGATION IS ONGOING. CUSTOM ULTRASONICS INC AGREED TO WORK WITH THE CENTER TO COMPLETE THEIR ANALYSIS OF THE INCIDENT IF NECESSARY, AS OF THIS DATE THE CENTER REPORTED NO HELP WAS NECESSARY. THERE MAY BE A POTENTIAL FOR INCREASED RISK ASSOCIATED WITH THIS BREACH. THERE HAS BEEN NO REPORTED INJURIES.

    Description of Event or Problem · 1

    (B)(6), CLAIMS THEY ARE RUNNING A FULL WASH/DISINFECT CYCLE BUT THE WASHER PRINTOUT SHOWS WASH ONLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CUSTOM ULTRASONICS INC. SYSTEM 83 PLUS MEDICAL WASHER-DISINFECTOR KOG CUSTOM ULTRASONICS INC

    Patients

    Seq Age Sex Outcome Treatment
    1