BEUDAMED
    FDA Adverse Event Summary report: N

    RELIANCE 444 WASHER

    MDR report key: 2222213 · Received August 24, 2011

    Report

    Report Number
    9680353-2011-00021
    Date Received
    August 24, 2011
    Date of Event
    August 5, 2011
    Report Date
    August 24, 2011
    Manufacturer
    STERIS CANADA CORPORATION
    Product Code
    LDS
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A STERIS SERVICE TECHNICIAN WAS ON-SITE AT THE USER FACILITY PRIOR TO THE REPORTED EVENT TO REPLACE THE WASHER/DISINFECTOR'S TEMPERATURE PROBE AND HAD REMOVED THE UPPER SERVICE PANEL. THE TECHNICIAN WAS UNABLE TO COMPLETE THE REPAIRS DURING THIS VISIT AND TAGGED THE UNITS AS 'UNDER REPAIR', HOWEVER HE DID NOT REINSTALL THE SCREWS ON THE UPPER SERVICE PANEL. THE OPERATOR SUBJECT OF THIS EVENT WAS ATTEMPTING TO OPERATE THE UNIT WHEN THE UPPER SERVICE PANEL FELL. AFTER THE REPORTED EVENT, THE STERIS TECHNICIAN COMPLETED THE NECESSARY REPAIRS, REINSTALLED THE SERVICE PANEL AND SCREWS, TESTED AND RETURNED THE UNIT TO SERVICE. THE STERIS SERVICE TECHNICIAN SUBJECT OF THIS EVENT RECEIVED RE-TRAINING ON PROPER EQUIPMENT TAG OUT PROCEDURES ON (B)(4), 2011.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT AN EMPLOYEE OPENED THE SIDE DOOR OF THE WASHER/DISINFECTOR AND THE UPPER SERVICE PANEL FELL AND IMPACTED HIS HEAD AND THUMB. THE EMPLOYEE WENT TO THE EMERGENCY ROOM WHERE HE RECEIVED A SPLINT FOR HIS THUMB. THE EMPLOYEE HAS RETURNED TO WORK WITH RESTRICTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RELIANCE 444 WASHER WASHER LDS STERIS CANADA CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Other