BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYSTEM 83 PLUS WASHER/DISINFECTOR

    MDR report key: 2326603 · Received October 11, 2011

    Report

    Report Number
    2523209-2011-00005
    Event Type
    Other
    Date Received
    October 11, 2011
    Date of Event
    September 28, 2011
    Report Date
    October 7, 2011
    Manufacturer
    CUSTOM ULTRASONICS, INC
    Product Code
    FLG
    PMA / PMN Number
    9833017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    CUSTOM ULTRASONICS CHIEF INFECTION CONTROL DIRECTOR RECEIVED A CALL FROM (B)(6), ON (B)(6) 2011 FROM (B)(6), THE EPIDEMIOLOGIST AT THE FACILITY. SHE IMPLIED THAT THE HOSP WAS EXPERIENCING WATER PROBLEMS, SINCE THE SPRING AND NOW HAVING THEM AGAIN DURING REPROCESSING OF BRONCHOSCOPES USING THE SYSTEM 83 PLUS. SHE IMPLIED THAT THE HOSP'S WATER PROBLEMS APPEAR RESPONSIBLE FOR POSSIBLE PT INJURIES (OR AT LEAST, A PSEUDO OUTBREAK DURING BRONCHOSCOPY). SERVICE TECHNICIANS HAVE BEEN DISPATCHED TO THE FACILITY ON MULTIPLE OCCASIONS, TO ENSURE THERE WAS NO MALFUNCTIONS WITH THE SYSTEM 83 PLUS. THE SYSTEM WAS EVALUATED AND DETERMINED TO BE FULLY OPERATIONAL AND WITHIN SPECS. THIS ADVERSE EVENT IS CONTRIBUTED TO THE HOSPITALS INTERNAL WATER SUPPLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYSTEM 83 PLUS WASHER/DISINFECTOR SYSTEM 83 PLUS FLG CUSTOM ULTRASONICS, INC SYSTEM 83 PLUS 2

    Patients

    Seq Age Sex Outcome Treatment
    1 Other