BEUDAMED
    FDA Adverse Event Other Summary report: N

    ESCHMANN EASY LIFT SHOULDER POSITIONER

    MDR report key: 1902395 · Received November 12, 2010

    Report

    Report Number
    1221538-2010-00008
    Event Type
    Other
    Date Received
    November 12, 2010
    Date of Event
    October 14, 2010
    Report Date
    October 18, 2010
    Manufacturer
    ALLEN MEDICAL SYSTEMS
    Product Code
    FWZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AN ALLEN MEDICAL REP VISITED THE USER FACILITY ON (B)(6) 2010 AND INSPECTED THE SUBJECT SHOULDER POSITIONER IN THE OPERATIONAL CONTEXT OF ITS USE. MEMBERS OF BOTH THE USER STAFF AND THE DISTRIBUTOR TEAM WERE ALSO PRESENT. IMMEDIATELY ON INSPECTION, IT WAS NOTED THAT THE SHOULDER POSITIONER HAD BEEN MODIFIED. THE NOTED EXTERNAL MODIFICATIONS INCLUDES THE LEFT SIDE RAIL LOCK (KNOB AND STUD ASSEMBLY.) THIS IS THE SIDE OF THE POSITIONER WHICH THE FACILITY REPORTS LEAVING THE RAIL SURFACE. ADDITIONALLY, THE SUBJECT OPERATING ROOM TABLE WHICH THE POSITIONER WAS INSTALLED ON WAS DAMAGED WITH THE RAIL STOP MISSING ON THE LEFT HAND SIDE, WHICH MAY HAVE BEEN A CONTRIBUTING FACTOR FOR THE INCIDENT. DESPITE THE MODIFICATIONS, THE ALLEN REP COULD NOT ADEQUATELY REPRODUCE THE FAILURE REPORTED DURING THE INSPECTION PERIOD. ONLY WHEN THE ATTACHING KNOBS WERE NOT PROPERLY TIGHTENED WAS THE UNIT FREE FROM THE TABLE RAIL INDICATING THAT INSTALLATION ERROR OR A FAILURE TO CHECK THE SETUP BETWEEN CASES MAY HAVE CONTRIBUTED TO THE EVENT. THE HOSP HAS TAKEN THE UNIT OUT OF USE.

    Description of Event or Problem · 1

    ALLEN MEDICAL RECEIVED A CALL FROM OUR DISTRIBUTOR ON (B)(6) 2010 DESCRIBING AN INCIDENT THAT HAD OCCURRED AT THE (B)(6). DURING USE, THE ALLEN-MANUFACTURED ESCHMANN EASY LIFT SHOULDER POSITIONER AND THE PT CAME FREE OF THE TABLE AND FELL TO THE FLOOR. THE FACILITY REPORTS IT WAS THE LEFT SIDE OF THE POSITIONER THAT DETACHED FROM THE TABLE RAIL. THE PT WAS EXAMINED AND X-RAYED WITH NO PERMANENT OR SERIOUS INJURIES SUSTAINED. THE SHOULDER POSITIONER HAD REPORTEDLY BEEN USED IN FOUR PREVIOUS CASES ON THE SAME DAY WITHOUT ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ESCHMANN EASY LIFT SHOULDER POSITIONER SHOULDER POSITIONER FWZ ALLEN MEDICAL SYSTEMS F-91002ESCH-A2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1