BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESCHMANN BEACH CHAIR

    MDR report key: 4503729 · Received February 6, 2015

    Report

    Report Number
    1221538-2015-00001
    Event Type
    Injury
    Date Received
    February 6, 2015
    Date of Event
    January 3, 2015
    Report Date
    February 6, 2015
    Manufacturer
    ALLEN MEDICAL SYSTEMS, INC.
    Product Code
    FWZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WE ARE UNABLE TO DETERMINE AT THIS TIME IF THERE WAS A DEVICE MALFUNCTION AS THE DEVICE HAS NOT BEEN MADE AVAILABLE TO ALLEN MEDICAL FOR EVALUATION. THE DEVICE IS (B)(4) PAST ITS STATED USEFUL LIFE OF 5 YEARS. THE SITE INVESTIGATION IDENTIFIES THE HIGH PROBABILITY OF AN IMPROPER AND OR UNSATISFACTORY CONNECTION OF THE SHOULDER POSITIONER TO THE TABLES' SIDE RAILS BY THE OR STAFF, LEADING TO ITS DETACHMENT, EITHER PARTIAL OR FULLY FROM THE TABLE TOP. THE SITE TECHNICIAN COULD NOT IDENTIFY ANY MAJOR OR OBVIOUS PROBLEMS WITH THE SHOULDER POSITIONER. THE FALL RESULTED IN A CUT TO THE HEAD AND A DELAY IN TREATMENT AS SURGERY WAS NOT ABLE TO BE PERFORMED AT THE TIME OF THE INCIDENT. THE USER FACILITY HAS FILED A REPORT WITH THE (B)(6) IN (REFERENCE# (B)(4)). IF THE DEVICE IS RETURNED OR FURTHER COMMUNICATION IS RECEIVED FROM THE USER FACILITY, ADDITIONAL EVALUATION WILL BE PERFORMED AND A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    THE INCIDENT OCCURRED ON SATURDAY (B)(6) 2015 AND THE SHOULDER POSITIONER WAS FITTED TO THE NORMAL HEAD END OF THE TABLE PRIOR TO THE START OF THE 1ST CASE. THIS CASE INVOLVED SUCCESSFUL SURGERY ON THE LEFT SHOULDER OF AN ELDERLY GENTLEMEN WEIGHING 82KG. THE 2ND PATIENT, A LADY WEIGHING 77.2KG WAS BOUGHT INTO THEATRE AND POSITIONED SUPINE ON THE TABLE TOP, WITH HER UPPER TORSO BEING POSITIONED ON THE SHOULDER POSITIONER, THE SHOULDER POSITIONER WAS RAISED SLIGHTLY AND A SMALL AMOUNT OF TREND APPLIED TO THE TABLE TOP. THE SHOULDER POSITIONER WAS RAISED FURTHER WITH ADDITIONAL TREND BEING APPLIED TO THE TABLE TOP CREATING A BEACH CHAIR TYPE OF POSITION. THE THEATRE STAFF WERE PREPARING FOR THE START OF THE SURGERY WHEN A LOUD BANG WAS HEARD AND THE ANAESTHETISED LADY WAS FOUND ON THE FLOOR, TO THE LHS OF THE TABLE WITH HER LEGS STILL RESTING ON THE TABLE TOP. AS A RESULT OF THE INCIDENT THE PATIENT SUSTAINED A CUT TO THE BACK OF HER HEAD' AND SIGNIFICANT DIZZINESS (A CONDITION SHE HAD PREVIOUSLY BUT HAS BEEN MADE WORSE SINCE THE HEAD INJURY).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88079 ESCHMANN BEACH CHAIR SHOULDER POSITIONER FWZ ALLEN MEDICAL SYSTEMS, INC. F-91002ESCH-A2

    Patients

    Seq Age Sex Outcome Treatment
    1 Other