BEUDAMED
    FDA Adverse Event Summary report: N

    AMSCO LOADING CART

    MDR report key: 3833045 · Received May 27, 2014

    Report

    Report Number
    3005899764-2014-00031
    Date Received
    May 27, 2014
    Date of Event
    May 1, 2014
    Report Date
    May 27, 2014
    Manufacturer
    STERIS MEXICO, S. DE R.L. DE C.V.
    Product Code
    FLE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A STERIS SERVICE TECHNICIAN ARRIVED ONSITE AND WAS UNABLE TO IDENTIFY THE SERIAL NUMBER SUBJECT OF THE EVENT LOADING CART. THE TECHNICIAN INSPECTED THE LOADING CART AND FOUND THAT THE RUBBER BUSHING INSIDE THE WHEEL WAS DAMAGED. THE TECHNICIAN HAD INSPECTED THE LOADING CART WITH THE FACILITY'S 3RD PARTY SERVICE PROVIDER WHO ORDERED THE PROPER COMPONENTS TO REPAIR THE UNIT. THE PROPER REPAIRS WERE MADE AND THE LOADING CART WAS RETURNED TO SERVICE; NO FURTHER ISSUES HAVE BEEN REPORTED. THE LOADING CART IS NOT UNDER STERIS SERVICE CONTRACT AND IS SERVICED AND MAINTAINED BY THE USER FACILITY.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT AN EMPLOYEE WAS MOVING THE LOADING CART AND THE WHEEL CASTER DISCONNECTED SUBSEQUENTLY CAUSING THE CART TO TIP AND ALLOWING THE INSTRUMENT TRAY TO FALL. THE EMPLOYEE ATTEMPTED TO CATCH THE INSTRUMENT TRAY SO IT WOULD NOT FALL TO THE GROUND BUT WAS UNABLE TO DO SO. THE INSTRUMENTS PRESENT WERE REPROCESSED BEFORE USE. NO MEDICAL TREATMENT WAS SOUGHT OR ADMINISTERED HOWEVER THE EMPLOYEE MISSED TIME FROM WORK. THE EMPLOYEE IS NOW BACK TO NORMAL WORK DUTIES AND IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311586 AMSCO LOADING CART STERILIZER ACCESSORY FLE STERIS MEXICO, S. DE R.L. DE C.V.

    Patients

    Seq Age Sex Outcome Treatment
    1