BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEN MEDICAL SYSTEMS SHOULDER CHAIR

    MDR report key: 804792 · Received June 9, 2006

    Report

    Report Number
    1221538-2006-00005
    Event Type
    Injury
    Date Received
    June 9, 2006
    Date of Event
    May 9, 2006
    Report Date
    June 5, 2006
    Manufacturer
    ALLEN MEDICAL SYSTEMS
    Product Code
    FWZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN RETURNED, A VISUAL INSPECTION OF THE DEVICE REVEALED THE PRESENCE OF FOREIGN DEBRIS IN THE SECTOR GEARS. (A THIN, WHITE PLASTIC PIECE WAS FOUND WEDGED INTO THE RIGHT SECTOR GEAR). THIS MAY HAVE CAUSED THE LOCKING BLADE NOT TO ENGAGE IN THE SECTOR GEAR - RESULTING IN THE REPORTED FAILURE. ONCE THE PLASTIC PIECE WAS REMOVED, THE ENGINEER ACTIVATED THE RELEASE LEVER AND ARTICULATED THE DEVICE THROUGH THE FULL RANGE OF MOTION. THE UNIT DID NOT FAIL AND FUNCTIONED PROPERLY THROUGH SEVERAL REPETITIONS. THE DEVICE IS HEAVILY USED AND STILL FUNCTIONS PROPERLY WHEN THE SECTOR GEARS ARE KEPT CLEAR. EVAL SHOWS THAT THIS DEVICE MAY CONTINUE TO BE USED IF THE DEVICE GUIDELINES ARE FOLLOWED. ADDITIONALLY, A VISUAL INSPECTION OF THE GEAR COVERS REVEALED THAT THEY WERE TORN. THIS CONDITION MAY BE THE RESULT OF THE GEAR COVERS INADVERTENTLY BEING JAMMED INTO THE SECTOR GEARS DURING SET-UP. THE SKIRT THAT COVERS THE BACK PORTION OF THE O-SC WAS NOT RETURNED.

    Description of Event or Problem · 1

    THE INCIDENT TOOK PLACE AT SURGERY CENTER AND INVOLVED THE USE OF AN ALLEN SHOULDER CHAIR WHICH SEES STEADY, REGULAR USE AT THIS FACILITY. JUST PRIOR TO THE START OF THE OPERATION, THE BACK OF THE SHOULDER CHAIR RELEASED ALLOWING THE ANESTHETIZED PT TO STRIKE THEIR HEAD/NECK AREA. ACCORDING TO THE FACILITY SPOKESMAN, THE CASE SURGEON, DR. DECIDED TO DISCONTINUE THE PROCEDURE BECAUSE THE PT'S BLOOD PRESSURE BECAME ELEVATED. ALL INDICATIONS ARE THAT ALL SUBSEQUENT TESTS AND EVALUATIONS COMPLETED BY THE STAFF WERE NEGATIVE. THE PT WAS LATER RELEASED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALLEN MEDICAL SYSTEMS SHOULDER CHAIR ALLEN SHOULDER CHAIR FWZ ALLEN MEDICAL SYSTEMS 0-SC-A3 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other