MAUDE Adverse Event Report: INVACARE TAYLOR STREET TDXSP ELECTRIC RED EURO WIDE BASE W/ 23-1 SSD GEAR BOX; WHEELCHAIR, POWERED

Model Number TDXSP-CG

Device Problems Sticking (1597); Device Operates Differently Than Expected (2913)

Patient Problems Pain (1994); Swelling (2091); No Code Available (3191)

Event Date 06/13/2016

Event Type  malfunction  

Manufacturer Narrative

Should additional information become available, a supplemental record will be filed.There is insufficient information regarding the whether there was a malfunction.Attempts have been made for additional information regarding the height of the curb, the speed at which the tdxsp-cg was going while going up the curb and whether the tdxsp-cg has been appropriately maintained.It has been previously reported that the end user hits curbs at excessive speeds.Mdr will be filed by invacare for the unintended movement reported.If additional information should become available, this record will be updated accordingly.User¿s manual review 1143190 rev.M (page 9): do not operate on roads, streets or highways.(page 19) warning! risk of serious injury or damage: driving (forward or reverse) down off *curbs/obstacles greater than 70mm (2.76 inches) b may cause your wheelchair to turn over and cause serious injury or damage to the wheelchair.Do not attempt to drive down off curbs/obstacles greater than 70mm (2.76 inches).Always stop before negotiating an obstacle.Approach slowly until caster wheels are approximately 18 inches (46 cm) away from the obstacle.Slowly apply power to move forward/reverse while negotiating the obstacle.(page 61) every six months, and as necessary, take your wheelchair to a qualified technician for a thorough inspection and servicing.Weekly, monthly, and periodic inspections should be performed by user/attendant between the six month service inspections.Regular cleaning will reveal loose or worn parts and enhance the smooth operation of your wheelchair.To operate properly and safely, your wheelchair must be cared for just like any other vehicle.Routine maintenance will extend the life and efficiency of your wheelchair.

Event Description

Provider states the end user alleges while going up a curb from coming off the street going into a driveway, the right side suspension arm went up and would not come down, the chair spun out and hit a parked car feet first.Provider states the end user alleged his foot was hurting.Provider states the end user is a heavy user and chair is driven all over the streets provider states no injury was alleged.End user called back and advised dealer stated should call invacare to advise he was injured.End user advised left big toe and top of the foot is swollen.End user advised left knee is twisted and in a lot of pain.End user advised when hit parked car it kind of twisted his body.End user advised he is in pain and iced it but has not sought medical attention.End user advised not able to put full weight on foot.End user could not provide any further information.No return done at this time due to dealer is servicing the chair.End user advised has a manual chair but not able to use due to right rotator cuff tear no fault of the chair.Update from consumer affairs on 6/21/2016: dealer states they cannot confirm height of the curb but end user admitted to going up a curb from the street into a driveway and they think that is what caused the suspension arm to stick.Dealer has confirmed end user was given a user guide.No further information provided or available.

• Brand Name: TDXSP ELECTRIC RED EURO WIDE BASE W/ 23-1 SSD GEAR BOX
• Type of Device: WHEELCHAIR, POWERED
• Manufacturer (Section D): INVACARE TAYLOR STREET; 1200 taylor street; elyria OH 44036
• Manufacturer (Section G): INVACARE TAYLOR STREET; 1200 taylor street; elyria OH 44036
• Manufacturer Contact: kevin guyton ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 5768538
• MDR Text Key: 48813727
• Report Number: 1525712-2016-02410
• Device Sequence Number: 1
• Product Code: ITI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 06/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: TDXSP-CG
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/14/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Weight: 73