BEUDAMED
    FDA Adverse Event Other Summary report: N

    ALPHA TRANCELL DELUXE

    MDR report key: 2485390 · Received March 7, 2012

    Report

    Report Number
    1000381138-2012-00003
    Event Type
    Other
    Date Received
    March 7, 2012
    Date of Event
    February 27, 2012
    Report Date
    February 27, 2012
    Manufacturer
    ARJOHUNTLEIGH
    Product Code
    IKY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED UNDER EXEMPTION (B)(4) BY ARJOHUNTLEIGH ON BEHALF OF THE MANUFACTURER ARJOHUNTLEIGH, A BRANCH OF ARJO (B)(4). SINCE ITS RELEASE IN 1997, THE MANUFACTURER HAS PRODUCED FOR THE GLOBAL MARKET: (B)(4) ALPHA TRANCELL CUSHIONS AND THIS IS THE FIRST RECORDED INSTANCE ((B)(4)) OF THIS TYPE OF INCIDENT HAVING OCCURRED. IN REGARDS TO THE DEVICE ITSELF, THE MANUFACTURER EVALUATED THE DEVICE AND CONFIRMED IT TO BE IN GOOD WORKING ORDER WITH THE COVER INTACT WITH NO RIPS OR TEARS. A FUNCTIONAL TEST WAS CARRIED OUT SUCCESSFULLY AND NO FAULTS WERE FOUND. THE MAIN BODY OF THE CUSHION HAS RUBBER STRAPS AND TIE STRAPS IN PLACE THAT FIX TO THE EXISTING CHAIR. THE COVER FITS LOOSELY OVER THE CUSHION WITH ELASTICATED CORNERS THAT FORM UNDER THE BODY OF THE CUSHION AT THE CORNERS. IN THIS INSTANCE, IT IS ALLEGED THAT THIS TOP COVER HAS MORE MOVEMENT (LOOSER) THAN THE LATER MODELS WHICH APPEAR TO FORM BETTER OVER THE CUSHION. AS THE MANUFACTURER CANNOT DETERMINE THE AGE OF THE CUSHION COVER (SPARE PART) OR THE AMOUNT ANY SERVICE HISTORY IT HAS UNDERTAKEN, IT WOULD BE DIFFICULT TO CONFIRM OR DENY THE CUSTOMERS CONCERNS OVER THIS. THE LOCAL FACILITY INSTALLS EACH OF THE SYSTEMS THEMSELVES AND NOT BY A QUALIFIED ARJOHUNTLEIGH SERVICE TECHNICIAN, SO ARJOHUNTLEIGH CANNOT CONFIRM IF THE COVER WAS FITTED CORRECTLY, INITIALLY. WHAT CAN BE CONFIRMED IS THAT DURING THE EVALUATION, THE CUSHION COVER FITTED CORRECTLY TO THE BODY OF THE CUSHION AND PERFORMS AS INTENDED FROM A THERAPEUTIC PERSPECTIVE. AT THIS TIME ARJOHUNTLEIGH CONSIDERS THIS TO BE AN ISOLATED FAILURE; HOWEVER IT IS OUR INTENTION TO CLOSELY MONITOR THESE TYPES OF EVENTS FOR TRENDING ANALYSIS AND FURTHER POST MARKET SURVEILLANCE INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT THE USER SLIPPED OFF THE ALPHA TRANCELL DELUXE CUSHION DURING USE. THE TOP COVER DISPLACED FROM THE LOOP BASE SHEET ASSEMBLY. THERE WERE NO REPORTED INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALPHA TRANCELL DELUXE IKY ARJOHUNTLEIGH

    Patients

    Seq Age Sex Outcome Treatment
    1 Other