BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RAZ DESIGN INC

    MDR report key: 7380997 · Received March 29, 2018

    Report

    Report Number
    3006055387-2018-00001
    Event Type
    Injury
    Date Received
    March 29, 2018
    Date of Event
    February 1, 2018
    Report Date
    November 20, 2018
    Manufacturer
    RAZ DESIGN INC.
    Product Code
    INN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    "THE RAZ-AT INVOLVED IN THE INCIDENT, WAS SUBJECTED TO A CLOSER INSPECTION. IT WAS NOTED THAT THE CABLE HOUSING FOR THE RIGHT TILT CABLE, RESPONSIBLE FOR CONTROLLING THE LOCKING GAS CYLINDER ON THE RIGHT SIDE OF THE CHAIR, HAS BEEN DISLODGED OUT OF THE SCREW FITTING ON MANY OCCASIONS AS INDICATED BY THE DAMAGE TO THE BLACK CABLE SHEATHING. IT WAS ALSO NOTED THAT THE RIGHT TILT CABLE WAS NOT AFFIXED TO THE TILT ASSIST PEDAL WITH A PLASTIC CABLE TIE, AS IS IT WOULD HAVE BEEN WHEN IT WAS SHIPPED FROM RAZ. THE PLASTIC CABLE TIE CONTROLS THE LOOPING OF THE CABLE WHEN THE CHAIR IS TILTED BACK AND PREVENTS THE RIGHT TILT CABLE FROM CATCHING THE END OF THE TILT ASSIST PEDAL AS WELL AS BEING PULLED OUT OF THE CABLE SCREW FITTING. WHEN THE CABLE FITTING IS OUT OF THE SCREW FITTING, THE LOCKING GAS CYLINDER WOULD BE EFFECTIVELY BE UNLOCKED, AS IF AN ATTENDANT WAS ACTIVATING THE TILT RELEASE LEVER. THE DISLODGED CABLE HOUSING MOST LIKELY, CONTRIBUTED TO THE UNINTENDED, UPRIGHT (TILT) MOVEMENT OF THE CHAIR. THE DISLODGING OF THE RIGHT CABLE SHOULD HAVE BEEN REPORTED TO THE EQUIPMENT MANAGER, TECHNICAL STAFF AT ASSISTED LIVING LEEDS, THE LOCAL DEALER OR DISTRIBUTOR. THE MEETING ALSO DISCLOSED THAT THE USER HAD NO UPPER BODY / TRUNK CONTROL AND THAT THE USER COULD NOT SAFELY SIT WITH HIS TRUNK IN THE UPRIGHT / VERTICAL POSITION. IT WAS DISCUSSED THAT THE ASSISTED LIVING FACILITY WHERE THE USER LIVED, HAD A NO-RESTRAINT POLICY WHICH PROHIBITED THE USE OF CHEST OR PELVIC BELTS. BECAUSE OF THESE CIRCUMSTANCES, THE ATTENDANTS ALWAYS HAD TO BE CAREFUL TO STOP THE UPWARD TILT OF THE RAZ-AT, AT AN ANGLE THAT WAS SAFE FOR THE USER. IT WAS POINTED OUT TO THE OCCUPATIONAL THERAPISTS AND TO THE STAFF AT ASSISTED LIVING LEEDS THAT THE RAZ-AT SHOULD HAVE BEEN SET UP IN A SAFER MANNER FOR THE USER. INSTEAD OF SETTING THE BACK ANGLE AT 90°, THE BACK SHOULD HAVE BEEN SET AT 95° AND THE TENSION-ADJUSTABLE UPHOLSTERY SHOULD HAVE BEEN ADJUSTED DEEPER AT THE TOP OF THE BACK TO PROVIDE ANOTHER ~3° OF FIXED BACK RECLINE. THESE TWO BUILT-IN ADJUSTMENTS WOULD HAVE POSITIONED THE USER'S TRUNK IN A MORE STABLE AND SAFER POSITION. THE SEAT ADJUSTMENT, ALSO NOT UTILIZED, COULD HAVE POSITIONED THE SEAT (AND USER'S PELVIS) ~1" FORWARD, WHICH WOULD ALSO HELPED IMPROVE THE USER'S TRUNK STABILITY. THE RAZ-AT WAS MOUNTED IN THE HIGHEST SEAT HEIGHT WHICH MEANT THE GAS STRUT TUBE COULD HAVE BEEN SET TO STOP THE TILT AT 7° FROM THE UPRIGHT POSITION BY ASSEMBLING THE GAS STRUT SCREW IN THE SECOND LOWEST HOLE. THIS ADJUSTMENT WOULD REQUIRE CUSTOM SPACERS ON THE GAS STRUTS TO PREVENT THE SEAT AND BACK ASSEMBLY FROM TILTING BEYOND A 40° RANGE. SPECIAL BACK MOUNTING PLATES ARE ALSO AVAILABLE TO LIMIT THE UPRIGHT POSITION OF THE USER'S TRUNK AND ARE AVAILABLE IN THE TWO FOLLOWING BACK ANGLE SETTINGS: 95°/100°/105° AND 105°/110°/115°. THESE BACK MOUNTING PLATES WILL REQUIRE CUSTOM TILT STOPS TO LIMIT THE REARWARD TILT AND MAINTAIN REARWARD STABILITY. IT IS OUR CONCLUSION THAT THE INCIDENT WAS A RESULT OF A MULTITUDE OF FACTORS INCLUDING THE IMPROPER ADJUSTMENT OF THE CHAIR AND NOT THE RESULT OF A SINGULARLY FAULTY COMPONENT. RAZ HAS MADE A COMMITMENT TO INCREASE KNOWLEDGE ABOUT THE WAYS IN WHICH THE DEALER/DISTRIBUTOR/CLINICIAN CAN OPTIMISE THE ADJUSTMENTS OF OUR HIGHLY ADAPTABLE PRODUCTS" - (B)(6) , PRESIDENT, ENGINEERING MANAGER, RAZ DESIGN INC.

    Additional Manufacturer Narrative · 1

    THERE ARE NO HYDRAULICS ON THE CHAIR AS REPORTED BY THE CAREGIVER. THERE ARE 2 LOCKING GAS STRUTS, WHOSE PURPOSE IS TO DAMPEN THE DOWNWARD TILTING OF THE SEAT AND TO ASSIST IN BRINGING THE SEAT OUT OF TILT. WHEN LOCKING GAS STRUTS FAIL, THEY LOSE PRESSURE. THE LOSS OF PRESSURE RESULTS IN REDUCED DAMPENING DURING TILTING AND REDUCED ASSIST WHILE BRINGING THE SEAT OUT OF TILT. THESE STRUTS ARE DESIGNED TO OPERATE WITHIN THE TEMPERATURE RANGE OF -30°C TO 80°C. THERE IS NO POSSIBLE WAY IN WHICH THE STRUTS CAN INCREASE THEIR INTERNAL PRESSURE TO CAUSE THE RAPID LIFTING ACTION AS DESCRIBED BY THE CAREGIVERS. UPON INSPECTION, THE LOCKING GAS STRUTS WERE FOUND TO BE IN NORMAL WORKING CONDITION, WHICH ALLOWED THE SEAT TO BE BROUGHT OUT OF TILT IN A SMOOTH AND CONTROLLED MANNER. A VIDEO RECORDING WAS MADE OF THE CHAIR BEING TESTED BY THE DISTRIBUTOR POST RETRIEVAL FROM THE CUSTOMER. THE RECORDING DEMONSTRATED THAT THE CHAIR FUNCTIONED NORMALLY. IT IS OUR BELIEF THAT THE CAREGIVERS ALLOWED THE CLIENT TO SLIP ONTO THE FLOOR AND THAT THEY BLAMED THE CHAIR TO AVOID BEING BLAMED FOR THE INCIDENT.

    Description of Event or Problem · 1

    AS REPORTED TO THE (B)(4): "CLIENT HAS BEEN SHOWERED AND WAS IN THE PROCESS OF BEING DRIED WHEN THE SHOWER CHAIR HYDRAULICS FAILED. THE SUDDEN MOVEMENT CAUSED CLIENT TO SLIDE FORWARD SO THE 2X CARERS PRESENT GUIDED HIM TO THE FLOOR"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223543 RAZ DESIGN INC RAZ-AT (ATTENDANT TILT SHOWER COMMODE CHAIR) INN RAZ DESIGN INC. Z300

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R