N2TFA TRANSPORT COMPANION MANUAL WHEELCHAIR
Received May 17, 2013 · Event occurred Jan 2, 2012
Report 9618009-2013-00002 · MDR key 3234100
Device
Product problems
- Device Operates Differently Than Expected
Patient
43 YR
- Fall
- Pain
Narrative
Additional Manufacturer Narrative
THIS CLAIM WAS REPORTED MORE THAN ONE YEAR AFTER THE EVENT HAPPENED. THERE WAS NO DEVICE RETURNED FOR EVALUATION. BASED ON THE PROVIDED PHOTOS, WE DID NOT FIND ANY MECHANISM DEFECT. ACCORDING TO OUR INSTRUCTION HANG TAG, THE WARRANTY PERIOD FOR FRAME IS 5 YEARS AND FOR OTHER COMPONENTS IS 1 YEAR. (SEE APPENDIX I, INSTRUCTION HANG TAG). HOWEVER, THIS DEVICE HAS BEEN USED FOR 11 YEARS WHICH HAS EXCEEDED IT'S USEFUL LIFE PERIOD AND THERE IS NO MAINTENANCE RECORD PROVIDED FOR THIS MODEL. WE ALSO CHECKED OUR HISTORICAL COMPLAINT RECORDS FOR THIS MODEL AND ALSO OTHER SIMILAR MODELS, HOWEVER, WE COULD NOT FIND ANY SIMILAR COMPLAINT ISSUES. MOREOVER, WE DO NOT HAVE ANY MARKET RECALL RECORD FOR THIS MODEL. WILL WAIT FOR FURTHER INFORMATION OR SAMPLE RETURNED FOR DETAILED EVALUATION.
Description of Event or Problem
PATIENT'S LIABILITY INSURANCE COMPANY MAILED ON (B)(6) 2013 RECEIVED (B)(6) 2013 WHICH WAS A YEAR AFTER THE DATE OF THE EVENT TO REPORT THE PATIENT FELL OUT OF THE CHAIR ON (B)(6) 2012. THE INSURANCE COMPANY STATED THEY RECEIVED PICTURES OF THE CHAIR BUT COULD NOT DETERMINE FROM THE PICTURES IF THERE WERE ANY VISIBLE SIGNS OF DEVICE FAILURE. THEY ASSUMED THE CHAIR MIGHT HAVE BROKEN BECAUSE IT WAS 11 YEARS OLD. THE ALLEGED PATIENT INJURIES INCLUDE BACK AND NECK STRAIN AND SHOULDER PAIN. WE HAVE SUBSEQUENTLY INTERVIEWED THE PATIENT'S INSURANCE COMPANY BY PHONE AND STATES SHE VISITED THE EMERGENCY ROOM ON THE DAY OF THE INCIDENT AND NO FRACTURES IN THE BACK, NECK OR SHOULDER WERE IDENTIFIED. THE PATIENT WAS PRESCRIBED NAPROZEN AND FLEXRIL. ADDITIONAL FOLLOW UP INCLUDED A VISIT TO CHIROPRACTOR. THE PATIENT ALSO HAD AN MRI AND THE CURRENT DIAGNOSIS IS NECK DYSFUNCTION SYNDROME. THEY DO NOT HAVE THE PATIENT WEIGHT. NEITHER DID SHE WANT TO RETURN THE WHEELCHAIR TO THE MANUFACTURER FOR INSPECTION. THERE IS NO SERVICE OR MAINTENANCE RECORDS SO FAR FOR THE 11 YEARS FOR THE WHEELCHAIRS. WE ARE ATTEMPTING TO TRY TO SET AN APPOINTMENT TO INSPECT THE CHAIR. RECEIVED...