BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEN MEDICAL SYSTEMS

    MDR report key: 892305 · Received August 10, 2007

    Report

    Report Number
    1221538-2007-00004
    Event Type
    Injury
    Date Received
    August 10, 2007
    Date of Event
    July 10, 2007
    Report Date
    August 10, 2007
    Manufacturer
    ALLEN MEDICAL SYSTEMS, INC.
    Product Code
    FWZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE BEACH CHAIR WAS NOT RETURNED FOR EVALUATION AS STATEMENTS FROM THE USER STAFF AND ALL VISUAL INDICATIONS WERE THAT A) THERE WAS NO DEVICE FAILURE, AND B) THAT THE DEVICE NEVER COLLIDED WITH THE FLOOR OR OTHERWISE SUSTAINED ANY DAMAGE. ALLEN MEDICAL CONCLUDED THE ROOT CAUSE OF THE INCIDENT WAS MISUSE BY THE HOSPITAL STAFF. TWO NURSES THERE AND THE OR DIRECTOR ADMITTED AT THAT TIME THAT THE TABLE WAS NOT SETUP PROPERLY FOR THE PATIENT PROCEDURE. FOLLOWING THE INCIDENT, THE ALLEN REP PROVIDED A CORRECTIVE IN-SERVICE TRAINING WITH THE STAFF. AFTERWARDS, THE OR DIRECTOR STATED SHE WAS COMFORTABLE WITH HER STAFF'S KNOWLEDGE OF THE DEVICE AND ITS PROPER USAGE NOW. THE OR DIRECTOR AGREED WITH THE CONCLUSION OF THIS INVESTIGATION - THAT THE INCIDENT WAS THE DIRECT RESULT OF USER-ERROR/MISUSE - DURING A PHONE CONVERSATION CONDUCTED BY AN ALLEN QUALITY REPRESENTATIVE. THIS INCIDENT OCCURRED DESPITE THE PROVISION OF ADEQUATE USER INSTRUCTIONS AND AT LEAST THREE IN-SERVICES PROVIDED BY TRAINED ALLEN REPRESENTATIVES. THE FIRST OF THESE WAS PROVIDED BY FORMER ALLEN SALES REP (DATE UNKNOWN) AND TWO SUBSEQUENT IN-SERVICE TRAINING SESSIONS WITH CURRENT ALLEN REP.

    Description of Event or Problem · 1

    THE FOLLOWING TOOK PLACE DURING A PATIENT PROCEDURE IN 2007. IT WAS REPORTED THAT THE STAFF AT THE USER FACILITY PREPARED FOR A PATIENT PROCEDURE BY SETTING THE ALLEN LIFT ASSIST BEACH CHAIR ON THE FOOT SECTION OF THE OR TABLE. THIS PORTION OF THE TABLE IS NOT INTENDED TO SUSTAIN THE WEIGHT OF THE DEVICE AND THE PATIENT. DURING THE BEGINNING OF THE PROCEDURE, THE TABLE SECTION COLLAPSED AT THE HINGE. THIS CAUSED THE SECTION OF THE TABLE (WITH THE ATTACHED CHAIR) TO STRIKE A DOCTOR'S FOOT - CAUSING INJURY. THERE WAS NO INJURY TO THE PATIENT. IT WAS INITIALLY REPORTED THAT THE DOCTOR MAY HAVE BROKEN A BONE IN HER FOOT, BUT ACCORDING TO THE OR DIRECTOR, MEDICAL EVALUATION SHOWED THERE TO BE NO FRACTURES. THE FOOT WAS JUST BRUISED AND VERY TENDER. THE DOCTOR WAS ABLE TO WALK AND WAS STILL WORKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALLEN MEDICAL SYSTEMS ALLEN LIFT ASSIST BEACH CHAIR FWZ ALLEN MEDICAL SYSTEMS, INC. A-91000-A5 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention