BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASP AUTOMATIC ENDOSCOPE REPROCESSOR

    MDR report key: 2018359 · Received March 14, 2011

    Report

    Report Number
    2150060-2011-00013
    Event Type
    Malfunction
    Date Received
    March 14, 2011
    Date of Event
    July 15, 2009
    Report Date
    March 7, 2011
    Manufacturer
    MEDIVATORS REPROCESSING SYSTEMS, DIV. OF MINNTECH
    Product Code
    FEB
    PMA / PMN Number
    K832458
    Removal / Correction Number
    Z-0628-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    TRANSITORY EYE IRRITATION. THIS MDR IS A DUPLICATE OF AN MDR FILED BY ADVANCED STERILIZATION PRODUCTS. MINNTECH WAS NOTIFIED OF THIS ISSUE ON (B)(6) 2011. ADVANCED STERILIZATION PRODUCTS (ASP), CO-MANUFACTURER, PROVIDES ALL MAINTENANCE AND TECHNICAL SUPPORT FOR THIS DEVICE. ASP HAS EVALUATED THIS DEVICE AND HAS FOUND CONTROLLER BOARD FAILURE, CAUSING CIDEX TO OVERHEAT, CREATING A STEAM THAT MAY HAVE BEEN THE CAUSE OF THE EYE IRRITATION. (B)(6) 2010, ASP SENT A HEATER DISCONNECTION LETTER TO THE FACILITY TO AVOID ANY OVER-HEATING ISSUES. NO ADDITIONAL PATIENT INFORMATION AVAILABLE AT TIME OF THIS REPORT. IF ADDITIONAL INFORMATION IS RECEIVED, MINNTECH WILL REVIEW UPON RECEIPT.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED FROM A FACILITY REGARDING THE HEATING OF THE CIDEX OPA IN THE AER. ASP REPORTED THE TECHNICIAN EXPERIENCED TRANSITORY EYE IRRITATION. AN ASP FSE WENT TO FACILITY TO ASSESS THE UNIT. CUSTOMER LATER STATED THE AER UNIT IS WORKING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASP AUTOMATIC ENDOSCOPE REPROCESSOR ENDOSCOPE DISINFECTANT FEB MEDIVATORS REPROCESSING SYSTEMS, DIV. OF MINNTECH

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR CIDEX OPA