BEUDAMED
    FDA Adverse Event Summary report: N

    60" LOADING CAR ASSEMBLY

    MDR report key: 4140613 · Received October 3, 2014

    Report

    Report Number
    3005899764-2014-00097
    Date Received
    October 3, 2014
    Date of Event
    September 5, 2014
    Report Date
    October 3, 2014
    Manufacturer
    STERIS MEXICO, S. DE R.L. DE C.V.
    Product Code
    FLE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A STERIS FIELD SERVICE TECHNICIAN INSPECTED THE CART AND CONFIRMED DAMAGE TO ALL INSTRUMENT RACK WHEELS. THIS UNIT IS MAINTAINED BY THE HOSPITAL MAINTENANCE DEPARTMENT. INVESTIGATION OF THIS EVENT IS CURRENTLY IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    THE TECHNICIAN CONFIRMED THE WHEELS HAD CHIPPED DUE TO USE. THE TECHNICIAN REPLACED THE RACK WHEELS AND RETURNED THE UNIT TO SERVICE. NO ADDITIONAL ISSUES HAVE BEEN REPORTED. THE RACK TIPPED AND MADE CONTACT WITH THE EMPLOYEE'S FINGER. THE EMPLOYEE RECEIVED A CUT FROM THE RACK. AN INSTRUMENT DID NOT CAUSE THE CUT.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED AN EMPLOYEE WAS INJURED WHILE REMOVING A LOADING CART FROM A CENTURY STERILIZER CHAMBER. WHILE REMOVING THE LOADING CART, THE INSTRUMENT RACK LOCATED ON TOP OF THE LOADING CART TIPPED CAUSING INSTRUMENTS TO FALL FROM THE CART. ONE OF THE INSTRUMENTS CUT THE EMPLOYEE'S FINGER. THE INJURED EMPLOYEE DID NOT SEEK MEDICAL TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620684 60" LOADING CAR ASSEMBLY LOADING CAR FLE STERIS MEXICO, S. DE R.L. DE C.V.

    Patients

    Seq Age Sex Outcome Treatment
    1