BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERIT 2 SECTION - ELECTRIC

    MDR report key: 1888550 · Received October 18, 2010

    Report

    Report Number
    3000140091-2010-00002
    Event Type
    Malfunction
    Date Received
    October 18, 2010
    Date of Event
    January 1, 2009
    Report Date
    August 20, 2009
    Manufacturer
    HUNTLEIGH HEALTHCARE LTD - AKRON
    Product Code
    FRK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    FROM FACILITY REP (B)(6): THE POSITIONING OF THE CONTROL LEVER WITH RESPECT TO THE CONTROL PIN ON THE STRUT WAS SUCH THAT THE LEVER WAS PERMANENTLY DEPRESSED. THIS MODEL OF COUCH HAS A PNEUMATIC STRUT CONTROLLED BY A LEVER TO ALLOW THE POSITION OF THE BACK REST PORTION TO BE RAISED OR LOWERED. WHEN THIS CONTROL LEVER IS RELEASED, THE PNEUMATIC STRUT LOCKS THE BACK REST OF THE COUCH IN THE DESIRED POSITION. ON THIS OCCASION, THE POSITIONING OF THE CONTROL LEVER WITH RESPECT TO THE CONTROL PIN ON THE STRUT WAS SUCH THAT THE LEVER WAS PERMANENTLY BEING DEPRESSED BY THE LEVER EVEN WHEN THE LEVER WAS RELEASED ALLOWING THE POSSIBILITY OF UNCONTROLLED LOWERING OF THE COUCH BACK REST. UPON INVESTIGATION, (B)(6) FOUND THAT THE CONTROL PIN TO LEVER POSITION CAN BE SET BY ROTATING THE BODY OF THE STRUT, WHICH BY MEANS OF A SCREW THREADED COLLAR ADJUSTS THE DISTANCE BETWEEN THE TWO TO GIVE CORRECT OPERATION OF THE RELEASE LEVER. ONCE SET CORRECTLY, HOWEVER, THERE IS NO LOCKING MECHANISM TO PREVENT ROTATION OF THE STRUT THROUGH EITHER LONG TERM USAGE OR INADVERTENT HANDLING TO ROTATE BACK TO AN INCORRECT POSITION. (B)(4) HEALTHCARE - (B)(4) INVESTIGATION: THE CONDITION OF THE DEVICE WAS GOOD, WITH THE FOLLOWING EXCEPTIONS - FOOT ADJUSTER AND (2) PIVOT POINT STAR-LOCKS WERE MISSING. THE ADJUSTER IS USED TO STABILIZE THE COUCH FOR UNEVEN FLOORS. THE LEG WITH THE FOOT ADJUSTER IS 50MM SHORTER, SO W/O THE ADJUSTER IT BECOMES UNSTABLE AND ROCKS HEAVILY. THE STAR-LOCKS HOLD THE FRAME TO THE PIVOT SHAFT. THE REP STATES THAT THE PRODUCT WAS NOT KNOWN TO BE DEFECTIVE, REGULARLY SERVICED PER THE MFR INSTRUCTIONS, AND USED PER THE MFR INSTRUCTIONS. THERE ARE BETWEEN 12-20 USERS OF THE PRODUCT ON-SITE. IT WAS FOUND THAT THE 200N GAS STRUT WHICH SUPPORTS THE BACKREST OPERATION WAS OUT OF ADJUSTMENT. THE RELEASE LEVER PIN WAS TOO CLOSE TO THE RELEASE LEVER, SO THAT IT WAS NOT LOCKING. THE PIN ADJUSTMENT IS PART OF ROUTINE SERVICE MAINTENANCE AND IT SHOULD HAVE HAD 2MM CLEARANCE SET THEN. WHEN LOOKING AT THE EVENTS LEADING TO THE FAILURE, THE CAUSE CAN BE FOUND IN THE FOLLOWING AREAS: SERVICING: AS ABOVE THE COUCH GAS STRUT, WHICH IS A WEARING AND A REPLACEABLE ITEM, SHOULD BE SET TO 2MM PIN CLEARANCE. IT WOULD THEN TAKE 4 COMPLETE 360 DEGREE TURNS OF THE CYLINDER TO ENGAGE THE STRUT. THE RECOMMENDATIONS IN OUR USER MANUAL ARE TO SERVICE THE COUCH ANNUALLY FOR LOW USAGE AND BI - ANNUALLY IN HEAVILY USED AREA. MALICIOUS TURNING OF THE STRUT: IT WOULD THEN TAKE 4 COMPLETE 360 DEGREE TURNS OF THE CYLINDER TO ENGAGE THE STRUT, SO THIS COULD NOT HAPPEN ACCIDENTALLY (REALISTICALLY). UNLESS THE STRUT IS TURNED MALICIOUSLY, OR THE STRUT WAS NOT SET CORRECTLY AT THE SERVICE INTERVAL, IT IS NOT POSSIBLE FOR THE STRUT TO UNLOCK. THE COUCH IS 5 YRS OLD, SO CLEARLY ADJUSTMENT WAS THE ISSUE AS THE PART DID NOT FAIL. WE HAVE LOOKED AT VARIOUS LOCKING METHODS AND THE GAS STRUT MFRS HAVE SUGGESTED THAT THE BEST AND ONLY METHOD WAS NOT TO LOCK THE STRUT, BUT TO FIT A LOCKNUT BETWEEN THE GAS STRUT THREAD AND THE CROSS TRUNNION, SO THAT IF THE STRUT IS TURNED MALICIOUSLY, THE LOCKNUT ACTS AS A SPACER AND PREVENTS THE PIN FROM EVER REACHING THE RELEASE LEVER FACE. THIS IS THE BEST WAS BECAUSE THE GAS STRUT THREAD IS SPIGOT-COMPRESSED AROUND A CYLINDER. IF THE THREAD WAS OVER TIGHTENED (MORE THAN 7 NN) IT COULD MALFUNCTION, CAUSING OTHER ISSUES. THE FACILITY WAS PROVIDED WITH LOCKNUTS (B)(4) AND A (B)(4) HEALTHCARE - (B)(4) REP DEMONSTRATED THE FITTING METHOD. THE COUCH IN QUESTION WAS FITTED WITH A NEW STRUT AND LOCKNUT. A SERVICE MANUAL, X USER MANUAL AND A F980 SERVICE CHECKLIST WAS GIVEN TO THE HOSPITAL - HIGHLIGHTING THE SERVICE REQUIREMENTS OF ANNUAL OR BI ANNUAL. THEY CAN FIT THE LOCKNUTS TO OTHER SIMILAR COUCHES, RETROSPECTIVELY. FOR PREVENTION AGAINST MALICIOUSLY ADJUSTED DEVICES, THE NEW STREAMLINE COUCHES HAVE GONE THROUGH A REVIEW AND WILL NOW HAVE STRUTS WITH THE SPACERS VIA (B)(4) TO PREVENT FURTHER RECURRENCES. IT SHOULD BE NOTED THAT NO OTHER MFRS LOCK THEIR STRUTS AT THIS TIME. AS THE GAS STRUTS ARE WEARING PARTS, MOST STRUTS WILL BE REPLACED IN DUE COURSE DEPENDING ON USAGE AT SERVICE INTERVALS. (B)(4) HEALTHCARE - (B)(4) SERVICE CENTERS WILL FIT A SPACER WHEN COUCHES ARE SERVICED. PROVIDING THE USER SERVICES THE COUCH AS INSTRUCTED BY THE USER MANUALS, (B)(4) HEALTHCARE - (B)(4) BELIEVES THE ACTIONS TAKEN WILL REDUCE ANY RISKS SIGNIFICANTLY. TO REPEAT WHAT IS STATED ABOVE, THE GAS STRUT CANNOT TURN ITSELF, AND CAN ONLY ROTATE IF DONE BY A PERSON. FROM A CORRECTLY ADJUSTED GAS STRUT (2MM CLEARANCE), IT TAKES 4 COMPLETE 360 DEGREES TURNS TO ENGAGE PIN, SO THE BACKREST COULD ONLY HAVE FAILED IF IT WAS TURNED MALICIOUSLY OR WAS NOT SET CORRECTLY AT THE SERVICE, AS ITS NOT POSSIBLE TO ACCIDENTALLY TURN THE STRUT 4 TURNS.

    Description of Event or Problem · 1

    THE MERIC 2 COUCH BACKREST UNEXPECTEDLY LOWERED DURING PT PROCEDURE - INJURING BOTH NURSE AND PT. THE HOSPITAL WAS VISITED TO CARRY OUT THE REPAIR AND WERE ADVISED AT THAT TIME THE PT'S INJURIES WERE MINOR. NO FURTHER INFO WAS GIVEN ABOUT THE PT OR INJURY DETAILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MERIT 2 SECTION - ELECTRIC CLINICAL COUCH FRK HUNTLEIGH HEALTHCARE LTD - AKRON 3222/2/SHS

    Patients

    Seq Age Sex Outcome Treatment
    1 Other