BEUDAMED
    FDA Adverse Event Summary report: N

    120 CART WASHER

    MDR report key: 3900571 · Received June 27, 2014

    Report

    Report Number
    9680353-2014-00045
    Date Received
    June 27, 2014
    Date of Event
    June 6, 2014
    Report Date
    June 27, 2014
    Manufacturer
    STERIS CANADA CORPORATION
    Product Code
    FLH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION OF THIS EVENT IS CURRENTLY IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    A STERIS SERVICE TECHNICIAN INSPECTED THE WASHER AND FOUND THE INCORRECT MODEL OF ILLUMINATION BULB INSTALLED AND NOT FUNCTIONING. IN ADDITION, HE FOUND A BLOWN CONTROL FUSE. THE TECHNICIAN REMOVED AND REPLACED THE BULB AND BLOWN FUSE. THE TECHNICIAN FURTHER INSPECTED THE WASHER AND FOUND SEVERAL COMPONENTS WERE NOT FUNCTIONING PROPERLY, SPECIFICALLY THE MOTOR FAN, TANK HEATER COIL AND WATER BOOSTER TANK. THE WASHER IS APPROXIMATELY 17 YEARS OLD AND IS SERVICED AND MAINTAINED BY THE USER FACILITY. STERIS RECOMMENDED TO THE USER FACILITY THAT THE WASHER BE REPLACED OR BE TAKEN OUT OF SERVICE DUE TO THE TECHNICIAN'S FINDINGS AND AGE OF THE UNIT. THE USER FACILITY CONTINUES TO USE THE WASHER UNTIL A DECISION ON STERIS' RECOMMENDED ACTIONS ARE MADE.

    Description of Event or Problem · 1

    THE USER FACILITY EXPRESSED DISSATISFACTION WITH THEIR 120 CART WASHER.

    Description of Event or Problem · 1

    THE USER FACILITY FURTHER REPORTED THAT A READY LIGHT IS NOT ILLUMINATING. NO INJURIES OR PROCEDURAL DELAYS/CANCELLATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378126 120 CART WASHER WASHER FLH STERIS CANADA CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1