BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHYSIOTHERAPY COUCH

    MDR report key: 2439534 · Received February 1, 2012

    Report

    Report Number
    3003984900-2012-00003
    Event Type
    Malfunction
    Date Received
    February 1, 2012
    Date of Event
    January 24, 2011
    Report Date
    March 22, 2011
    Manufacturer
    HUNTLEIGH HEALTHCARE LTD - AKRON
    Product Code
    FQO
    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). PLEASE NOTE THAT PREVIOUS MEDWATCH REPORTS FOR THIS PRODUCT MAY HAVE BEEN SUBMITTED FOR THE MANUFACTURING SITE HUNTLEIGH HEALTH LTD. AS OF 2011, THAT NUMBER WAS DE-ACTIVATED DUE TO THE SITE NO LONGER SHIPPING PRODUCT TO THE USA. GOING FORWARD, COMPLAINTS RELATED TO THIS PRODUCT ARE TO BE HANDLED BY ARJOHUNTLEIGH, A BRANCH OF ARJO (B)(4). EVALUATION SUMMARY: THERE HAVE BEEN TWO PREVIOUS REPORTS OF UPHOLSTERY BEING RIPPED OF THE FRAMEWORK, THESES WERE AS FOLLOWS; IN BOTH REPORTS ALTHOUGH ON DIFFERENT COUCHES AND SECTIONS OF THE COUCH THE UPHOLSTERY WAS LIFTED FROM THE FRAME AND DAMAGED. IT WAS FOUND THAT IN BOTH INSTANCES THE RELEASE MECHANISM FOR THE ADJUSTABLE GAS STRUT HAD GONE OUT OF ADJUSTMENT ALLOWING THE UPHOLSTERY TO BE FORCED AGAINST THE METAL FRAMEWORK. BOTH INSTANCES WERE REPORTED TO THE (B)(4). HOWEVER, IN THIS INSTANCE FOOT SECTION UPHOLSTERY WAS RIPPED FROM THE FRAME WHILST THE CLIENT WAS EITHER KNEELING OR APPLYING PRESSURE TO THE SECTION WHICH IS FIRST REPORT OF THIS NATURE. (B)(4). IN FACT THE METHOD OF FIXING/FITTING UPHOLSTERY USING A NUT INSERT AND 6MM SCREW IS USED BY MOST COUCH MANUFACTURERS, AND WHEN YOU CONSIDER THAT COUCHES HAVE BETWEEN TWO AND FOUR SECTIONS OF UPHOLSTERY THIS METHOD IS VERY RELIABLE. THERE ARE NO RECORDED ABNORMALITIES IN THE MANUFACTURING RECORDS. ALSO, THERE HAVE BEEN NO RECALLS OR DISTRIBUTION OF TECHNICAL LEAFLETS. AS FAR AS WE CAN ASCERTAIN THE COUCH HAS WORK PERFECTLY WELL FOR THE LAST 3 YEARS AND THE COUCH WAS IN GOOD CONDITION APART FROM THE INCIDENT DAMAGE. HOWEVER, THE COUCH IS NOT MAINTAINED BY OUR COMPANY AND THERE WAS NO SERVICE STICKERS FOUND ON THE COUCH. NONE OF THE STAFF AT THE FACILITY WERE ABLE TO PROVIDE ANY EVIDENCE OF SERVICING, SO PRESUMABLY THIS COUCH HAS NOT BEEN SERVICED ANNUALLY AS RECOMMENDED BY THE USER MANUAL SO IT SHOULD HAVE SERVICED AS MINIMUM OF TWICE AS IT THREE YEARS OLD. THE METAL INSERTS HAD BEEN PULLED FROM THE UPHOLSTERY WOOD AND THE FOOT SECTION WAS LOWERED TO THE FLOOR. THE GAS STRUT EYELET WAS BROKEN AND THE GAS STRUT PISTON WAS SPONGY I.E. IT HAD 2 OR 3 CM OF PLAY ON THE PISTON, INDICATING IT WAS NOT LOCKING FULLY. SPONGY OR SPRINGY PISTON STRUT IS DUE TO OIL/AIR LEAKS IN THE PISTON SEALS, USUALLY CAUSED BY LIFTING THE COUCH BY THE SECTION, OVERLOADING IT, OR OPERATING IT W/O USING THE LEVER. HOWEVER, IN THIS INCIDENT IT'S NOT POSSIBLE TO TELL WHETHER THE GAS STRUT SPRUNG (AIR LEAK) DUE TO THE FAILURE OF IF IT WAS FAULTY BEFORE THE FAILURE. THE WEIGHT LIMIT WAS EXCEEDED AT THE TIME OF THE INCIDENT AS THE USER APPLIED THEIR FULL BODY WEIGHT (B)(6) TO THE FOOT SECTION BY KNEELING ON THE SECTION, WHILST THE PATIENT WAS SITTING ON THE MID/LEG SECTION. THEREFORE, WEIGHT LIMIT WAS EXCEEDED ON THIS OCCASION, BECAUSE THE SECTION IS INTENDED TO SUPPORT THE PATIENT'S LEGS. ALTHOUGH THE SWL OF THE COUCH IS 225KGS, THE MAIN BULK OF THE WEIGHT SHOULD BE ON THE FIXED MID-SECTION, NOT THE MOVEABLE SUPPORTING SECTIONS. IT IS POSSIBLE THAT A COMBINATION OF FACTORS HAVE COME TO GATHER; WE KNOW THAT THE COUCHES HAVE BEEN RELOCATED AND IT IS POSSIBLE THAT DURING THAT MOVE THE PORTERS MAY HAVE INADVERTENTLY LIFTED THE COUCH BY THE FOOT AND HEAD SECTION. THIS COULD HAVE CAUSED THE GAS STRUT TO BE SPONGY, AND COULD HAVE LOOSENED THE UPHOLSTERY CREATING THE ENVIRONMENT FOR THE DETACHMENT OF THE UPHOLSTERY SECTION WHEN THE USER KNEELED ON THE SECTION. AS CONSEQUENCE OF THE INCIDENT AS PRECAUTION WE HAVE CHECKED THE OTHER COUCHES IN THE PHYSIOTHERAPY DEPT. TO ENSURE; THE GAS STRUTS OPERATE CORRECT AND IF NOT ARE REPLACED, ALSO THAT THE UPHOLSTERED SECTIONS ARE FITTED CORRECTLY AND THE NUT INSERTS ARE SECURE. WE HAVE RECOMMENDED TO THE DEPT. THAT THE COUCHES BE SERVICED ANNUALLY AS PER THE RECOMMENDATIONS IN THE IFU. THEREFORE, AS THIS IS OUR FIRST INCIDENT AND APPEARS TO BE ISOLATED ISSUE, AND WE DO NOT PROPOSE ANY FURTHER ACTION OTHER THAN THOSE ALREADY TAKEN AT THIS TIME. WE SHALL CONTINUE TO MONITOR FOR ANY FURTHER INCIDENTS OF THIS NATURE AND WILL OF COURSE INFORM THE RELEVANT (B)(4) IF THESE SHOULD ARISE, BUT IN THE MEANTIME, WE CONSIDER THIS CLOSED. PREPARED BY (B)(4).

    Description of Event or Problem · 1

    THE LOWER PART OF THE COUCH (WHERE THE FEET ARE KEPT) BECAME UNATTACHED FROM THE METAL FRAME WHEN THE PHYSIOTHERAPIST WAS TREATING A PATIENT. THE PHYSIOTHERAPIST KNEE WAS RESTED ON THAT PART OF THE COUCH, WHEN TREATING THE PATIENT. NO INJURIES TO THE PATIENT OR PHYSIOTHERAPIST WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHYSIOTHERAPY COUCH CLINICAL COUCH FQO HUNTLEIGH HEALTHCARE LTD - AKRON 2231A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other