BEUDAMED
    FDA Adverse Event Other Summary report: N

    ALLEN MEDICAL SYSTEMS

    MDR report key: 1061718 · Received June 13, 2008

    Report

    Report Number
    1221538-2008-00003
    Event Type
    Other
    Date Received
    June 13, 2008
    Date of Event
    May 1, 2008
    Report Date
    May 15, 2008
    Manufacturer
    ALLEN MEDICAL SYSTEMS, INC.
    Product Code
    FWZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RETURN OF THE DEVICE, ENGINEERING EVAL REVEALED THE PUSH BUTTON RELEASE WAS LODGED INSIDE THE SUPPORT ROD AND RENDERED INOPERABLE. THE END STOP ON THE SUPPORT ROD WAS ALSO MISSING. PER THE INSTRUCTIONS FOR USE, THE CHAIR IS TO BE CHECKED BEFORE EACH USE. IF THE TWO COMPONENTS WERE FUNCTIONAL ON THE UNIT AS THEY ARE DESIGNED AND SOLD, THE SUPPORT RODS COULD NOT HAVE COME FREE FROM THE CHAIR FRAME AND THE INCIDENT WOULD NOT HAVE OCCURRED. THE EVAL CONCLUDED THAT THE INCIDENT WAS THE RESULT OF CUSTOMER MISUSE. THIS IS DUE TO THE FACT THAT THE BEACH CHAIR WAS USED FOR THIS PROCEDURE AFTER THE DEVICE WAS ALREADY DAMAGED.

    Description of Event or Problem · 1

    IN 2008, REP ALLEN WAS CONTACTED BY A DISTRIBUTOR ABOUT A PATIENT-INVOLVED INCIDENT INVOLVING ONE OF OUR BEACH CHAIRS. ALLEN MEDICAL RECEIVED A COPY OF THE FACILITY'S VOLUNTARY MEDWATCH FILING FROM THE DISTRIBUTOR. ACCORDING TO THE REPORT, A PT - WHO WAS UNDER GENERAL ANESTHESIA - WAS BEING POSITIONED IN A BEACH CHAIR PRIOR TO THE START OF A PROCEDURE. WHEN THE USER ATTEMPTED TO EXTEND THE HEADREST SUPPORT RODS, THE RODS EXTENDED BEYOND THE LOCKING POSITION AND CAME FREE FROM THE CHAIR FRAME. THIS LEFT THE PT'S HEAD UNSUPPORTED. THE PT'S HEAD WAS KEPT SUPPORTED BY STAFF MEMBERS ON HAND AND THERE WAS NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALLEN MEDICAL SYSTEMS BEACH CHAIR/DIRECT SHOULDER POSITIONER FWZ ALLEN MEDICAL SYSTEMS, INC. F-SCBER-A3 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention