QUICKIE WHEELCHAIR

Report

Report Number: 9616084-2023-00016
Event Type: Malfunction
Date Received: June 8, 2023
Date of Event: May 9, 2023
Report Date: June 8, 2023
Manufacturer: SUNRISE MEDICAL (US) LLC
Product Code: IOR
PMA / PMN Number: K072153
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: OR, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 0

BACKGROUND INFORMATION: ALL OWNER MANUALS CONTAIN INFORMATION REGARDING MAINTENANCE SCHEDULES FOR MANUAL AND POWER WHEELCHAIRS. IT IS THE DEALER'S RESPONSIBILITY TO MAKE SURE THAT USERS RETURN ON A SCHEDULED BASIS TO MAINTAIN THEIR WHEELCHAIRS PROPERLY. THIS MAINTENANCE REQUIREMENT INCLUDES ALL FASTENERS (NUTS, BOLTS, ETC.) ARE SECURELY FASTENED, THERE IS NO UNUSUAL WEAR AND TEAR ON MECHANICAL ITEMS, AND ELECTRONIC ITEMS ARE FULLY FUNCTIONAL. IT IS THE DEALER'S RESPONSIBILITY TO ENSURE THAT MAINTENANCE REQUIREMENTS ARE COMMUNICATED TO THE USER, AND FAILURE TO ADHERE TO THE MANUFACTURER'S MAINTENANCE REQUIREMENTS IS A FAILURE ON THE PART OF THE DEALER AND/OR END USER. SOME ITEMS (E.G., BATTERIES, STRUTS, ETC.) REQUIRE REPLACEMENT AT SCHEDULED INTERVALS AS PROVIDED IN THE INSTRUCTIONS FOR USE (IFU) THAT IS PROVIDED WITH EVERY SUNRISE MEDICAL PRODUCT. THESE MAINTENANCE SCHEDULES ARE PROVIDED SO THAT BOTH THE DEALER AND THE USER HAVE SPECIFIC INFORMATION REGARDING THE FREQUENCY OF PREVENTIVE AND ROUTINE MAINTENANCE, AND CERTAIN ISSUES TO WATCH FOR (E.G., LOOSE BOLTS, WORN STRAPS, BATTERIES NOT RETAINING A CHARGE, WORN TIRES, ETC.). ADHERENCE TO THESE MAINTENANCE SCHEDULES IS CRUCIAL FOR THE CONTINUED SAFE FUNCTIONING AND USE OF THE PRODUCT. IF THESE MAINTENANCE SCHEDULES ARE NOT ADHERED TO INJURY TO THE USER MAY RESULT. CHAIRS ARE SUBJECT TO STATIC, FATIGUE AND IMPACT TESTING PER THE REQUIREMENTS OF ANSI/RESNA OR ISO 7176 SECTION 8 TO ENSURE INTEGRITY OF THE CHAIR FOR THE LIFE OF THE DEVICE. THIS POTENTIAL FAILURE MODE ASSOCIATED TO LOOSENING WHEEL LOCK HARDWARE IS ADDRESSED IN USE FMEA, "UFMEA_ EIF6_Q2.XLSM" RISK ID 111. THE QUICKIE QXI /QX OWNER MANUAL (120346 REV H) STATES: "WARNING PROPER INFLATION EXTENDS THE LIFE OF YOUR TIRES AND MAKES YOUR CHAIR EASIER TO USE. 1. DO NOT USE THIS CHAIR IF ANY OF THE TIRES ARE UNDER- OR OVER-INFLATED. CHECK WEEKLY FOR PROPER INFLATION LEVEL, AS LISTED ON THE TIRE SIDEWALL. 2. LOW PRESSURE IN A REAR TIRE MAY CAUSE THE WHEEL LOCK ON THAT SIDE TO SLIP AND ALLOW THE WHEEL TO TURN WHEN YOU DO NOT EXPECT IT. 3. LOW PRESSURE IN ANY OF THE TIRES MAY CAUSE THE CHAIR TO VEER TO ONE SIDE AND RESULT IN A LOSS OF CONTROL. 4. OVER-INFLATED TIRES MAY BURST. IF YOU FAIL TO HEED THESE WARNINGS DAMAGE TO YOUR CHAIR, A FALL, TIP-OVER OR LOSS OF CONTROL MAY OCCUR AND CAUSE SEVERE INJURY TO THE RIDER OR OTHERS. "WARNING REAR WHEEL LOCKS ARE NOT DESIGNED TO SLOW OR STOP A MOVING WHEELCHAIR. USE THEM ONLY TO KEEP THE REAR WHEELS FROM ROLLING WHEN YOUR CHAIR IS AT A COMPLETE STOP. 1. NEVER USE REAR WHEEL LOCKS TO TRY TO SLOW OR STOP YOUR CHAIR WHEN IT IS MOVING. DOING SO MAY CAUSE A FALL OR TIP-OVER. 2. TO KEEP THE REAR WHEELS FROM ROLLING, ALWAYS SET BOTH REAR WHEEL LOCKS WHEN YOU TRANSFER TO OR FROM YOUR CHAIR. 3. LOW PRESSURE IN A REAR TIRE MAY CAUSE THE WHEEL LOCK ON THAT SIDE TO SLIP AND MAY ALLOW THE WHEEL TO TURN WHEN YOU DO NOT EXPECT IT. 4. MAKE SURE LOCK ARMS EMBED IN TIRES AT LEAST 1/8 INCH (3MM) WHEN LOCKED. IF YOU FAIL TO DO SO, THE LOCKS MAY NOT WORK. IF YOU FAIL TO HEED THESE WARNINGS DAMAGE TO YOUR CHAIR, A FALL, TIP-OVER OR LOSS OF CONTROL MAY OCCUR AND CAUSE SEVERE INJURY TO THE RIDER OR OTHERS. "WARNING THE OWNER AND/OR CAREGIVER IS RESPONSIBLE FOR MAKING SURE THAT IT HAS BEEN SETUP AND ADJUSTED BY A TRAINED SERVICE PROFESSIONAL UNDER THE ADVICE OF A HEALTHCARE PROFESSIONAL. THE CHAIR MAY REQUIRE PERIODIC SAFETY AND FUNCTION CHECKS OR CERTAIN TOOL FREE ADJUSTMENTS THAT CAN BE PERFORMED BY THE OWNER, CAREGIVER, OR AUTHORIZED DEALER IF DESIRED. ALWAYS USE PARTS AND/OR ACCESSORIES THAT HAVE BEEN RECOMMENDED OR APPROVED BY SUNRISE MEDICAL WHEN SERVICING THIS CHAIR. 1. PROPER MAINTENANCE WILL IMPROVE PERFORMANCE AND EXTEND THE USEFUL LIFE OF YOUR CHAIR. 2. CLEAN YOUR CHAIR REGULARLY. THIS WILL HELP YOU FIND LOOSE OR WORN PARTS AND MAKE YOUR CHAIR EASIER TO USE. YOU WILL NEED A MILD DETERGENT SOLUTION AND PLENTY OF CLEANING RAGS. 3. IF DISCOVERED, REPAIR OR REPLACE LOOSE, WORN, BENT OR DAMAGED PARTS BEFORE USING THE CHAIR. 4. TO PROTECT YOUR INVESTMENT, HAVE ALL MAJOR MAINTENANCE AND REPAIR WORK DONE BY YOUR AUTHORIZED DEALER. 5. INSPECT AND MAINTAIN THIS CHAIR STRICTLY PER THE MAINTENANCE CHART. 6. IF YOU DETECT A PROBLEM, MAKE SURE TO ORDER PARTS, OR HAVE SERVICE, AND REPAIR WORK DONE AT YOUR AUTHORIZED DEALER BEFORE USE. 7. AT LEAST ONCE PER YEAR, HAVE A COMPLETE INSPECTION, SAFETY CHECK, AND SERVICE OF YOUR CHAIR MADE BY AN AUTHORIZED DEALER. ". WHEEL LOCKS SHOULD BE CHECKED AT WEEKLY INTERVALS; MAKE SURE ALL NUTS AND BOLTS ARE SNUG. IF AN ITEM IS NOT WORKING PROPERLY, PLEASE CONTACT YOUR AUTHORIZED DEALER. THE FUNCTIONALITY AND EFFECTIVENESS OF WHEEL LOCKS ON MANUAL WHEELCHAIRS IS DEPENDENT ON A VARIETY OF FACTORS INCLUDING POSITION OF THE WHEEL LOCK RELATIVE TO THE REAR WHEEL, ACCESSIBILITY OF THE ACTUATION LEVER TO THE RIDER AND PROXIMITY OF THE MECHANISM TO OTHER ACCESSORIES AND COMPONENTS MOUNTED TO THE CHAIR. THE COMBINATION OF THESE FACTORS MAKES THE IDEAL POSITIONING OF THE WHEEL LOCK UNIQUE TO EACH DEVICE. IN ADDITION, IT IS FORESEEABLE THAT MANUAL WHEELCHAIRS WILL BE ADJUSTED AND RECONFIGURED IN THE FIELD TO MEET THE CHANGING NEEDS OF THE RIDER. AS A RESULT, WHEEL LOCKS ON MANUAL WHEELCHAIRS ARE PURPOSEFULLY DESIGNED WITH A HIGH LEVEL OF ADJUSTABILITY WHICH ALLOWS THEM TO FUNCTION PROPERLY IN ALL REQUIRED UNIQUE MOUNTING LOCATIONS WHILE PROVIDING THE FLEXIBILITY REQUIRED TO MEET THE CHANGING NEEDS OF THE WHEELCHAIR RIDER. REMOVING THIS ADJUSTABILITY WOULD LIMIT AVAILABLE CONFIGURATIONS AND FORCE THE RIDER TO COMPROMISE THEIR OPTIMAL SEATING POSITION OR POTENTIALLY AFFECT THE OVERALL EFFECTIVENESS OF THE WHEEL LOCKS. DISCUSSION: ALL SUNRISE MEDICAL MANUAL WHEELCHAIRS ARE PROVIDED WITH WHEEL LOCKS. AFTER EVALUATING THE COMPLAINT, IT WAS DETERMINED THAT BASED ON SIMILAR COMPLAINTS AND PRODUCTS RECEIVED, THE MOST PROBABLE CAUSE WOULD BE HARDWARE LOOSENING OVER TIME LEADING TO INSUFFICIENT WHEEL LOCKING FORCE. BASED ON THE IFU, THE USER OR DEALER SHOULD BE PERFORMING MAINTENANCE TO REDUCE THE RISK OF WHEEL LOCKS BECOMING NON-FUNCTIONAL OR BROKEN. THE MAINTENANCE OF THE PRODUCT HARDWARE IS THE DEALER/ PROVIDER'S RESPONSIBILITY BASED ON THE USER'S CONDITION. THIS REQUIREMENT CANNOT BE DETERMINED BY SUNRISE MEDICAL AS WE DO NOT KNOW THE CONDITION OF THE END USER, NOR THE SPECIFIC NEEDS OF THEIR DISABILITY. CONCLUSION: BASED ON THE IFU, THE USER OR DEALER SHOULD BE PERFORMING MAINTENANCE TO REDUCE THE RISK OF WHEEL LOCKS BECOMING NON-FUNCTIONAL OR BROKEN. THE PRODUCT IN QUESTION MET ALL PRODUCT SPECIFICATIONS BEFORE RELEASE FOR DISTRIBUTION AT THE TIME OF SHIPPING TO THE CUSTOMER. THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. THERE IS NO CLAIM OF INJURY IN THIS CASE. THE FAILURE MODE OF NON-FUNCTIONING WHEEL LOCKS HAS BEEN PREVIOUSLY REPORTED PER 21 CFR 803.50. THIS COMPLAINT WAS RE-EVALUATED DURING A RETROSPECTIVE REVIEW AND REMEDIATION EFFORT RESULTING FROM IMPROVEMENTS MADE TO THE COMPANY'S COMPLAINT HANDLING AND ADVERSE EVENT REPORTING PROCESSES TO ENSURE PATIENT SAFETY AND REGULATORY COMPLIANCE. THIS MDR IS BEING FILED BASED ON THE OUTCOME OF THAT RETROSPECTIVE REVIEW. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, SUNRISE MEDICAL WILL FILE A SUPPLEMENTAL REPORT.

Description of Event or Problem · 0

THE DEALER STATED THAT PER THE END USER, THE RIGHT WHEEL LOCK EXTENSION IS NOT STAYING ATTACHED ONTO WHEEL LOCK. HE STATED THE HANDLE WOULD COME OFF WHEN TRYING TO ENGAGE THE WHEEL LOCK. NO INJURIES OR ADVERSE IMPACT TO THE USER WAS REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1274854	QUICKIE WHEELCHAIR	WHEELCHAIR MECHANICAL	IOR	SUNRISE MEDICAL (US) LLC	QUICKIE QXI

Patients

Seq	Age	Sex	Outcome	Treatment
1		Unknown