BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYSTEM 83 PLUS 2

    MDR report key: 3703444 · Received February 18, 2014

    Report

    Report Number
    2523209-2014-00003
    Event Type
    Injury
    Date Received
    February 18, 2014
    Date of Event
    January 30, 2014
    Report Date
    January 30, 2014
    Manufacturer
    CUSTOM ULTRASONICS INC.
    Product Code
    KOG
    PMA / PMN Number
    K983017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    UPON INVESTIGATION, THE CLINICAL COORDINATOR STATED THAT THE USER DID NOT HAVE BURNS TO HER FACE, THE CLINICAL COORDINATOR, (B)(4), STATED THE USER DID HAVE PPE (FACE SHIELD, GLOVES AND GOWN) AT THE TIME OF THE INCIDENT. THE USER WENT TO THE EMERGENCY ROOM AND WAS TREATED FOR INHALATION AND BURNING EYES. THE USER WAS TREATED, RELEASED AND REPORTED BACK TO WORK. THE SERVICE TECH STATED THAT THE HINGE ON THE DOOR OF THE WASHER-DISINFECTOR WAS BROKEN DUE TO A FOREIGN OBJECT BEING LEFT UNDER THE LID WHILE CLOSING IT. THIS RESULTED IN MISALIGNMENT OF THE LID, THE LID WAS LEFT IN THIS POSITION CAUSING A GAP TO BE PRESENT. THIS GAP ALLOWED A LOOSE ADAPTER IN THE CHAMBER TO SPRAY THE DISINFECTANT CHEMICAL DOWN THE FRONT OF THE MACHINE. THE TECH CHECKED THE FUNCTION OF THE UNIT, NO LEAKS WERE FOUND. THE LID WAS PROPERLY ADJUSTED.

    Description of Event or Problem · 1

    DURING USE OF THE SYSTEM 83 PLUS, THE DISINFECTANT CIDEX LEAKED ON THE FLOOR FROM THE MACHINE. IT WAS REPORTED THAT THE USER WENT TO THE EMERGENCY ROOM DUE TO CHEMICAL BURN TO FACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    101761 SYSTEM 83 PLUS 2 ENDOSCOPE WASHER-DISINFECTOR KOG CUSTOM ULTRASONICS INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization