MAUDE Adverse Event Report: INVACARE TAYLOR ST. TDXSP FOR FORMULA CG WITH MK6I; WHEELCHAIR, POWERED

Model Number NA:TDXSP-CG

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Bone Fracture(s) (1870)

Event Type  Injury  

Manufacturer Narrative

The locking cylinders have been returned and an expanded evaluation is pending.The underlying cause of the left drive wheel staying in the air could not be determined due to the return evaluation not being complete at this time.Replacement cylinders have been sent.At the time of the event the end user was not wearing their seat positioning strap and using a non-invacare accessory ankle restraint.The owner¿s manual lists the following warnings and instructions: always wear your seat positioning strap.Warning! risk of injury or damage: use of non-invacare accessories may result in injury or damage.Do not use non-invacare accessories.Should additional information become available, a supplemental record will be filed.

Event Description

Provider states that about 2 weeks ago the gas locking cylinders were replaced on this chair.Provider states the left drive wheel stayed in the air while going down a ramp, which caused the chair to spin around and the patient to fall out of the chair.Provider states the patient did not have a seat belt on but she did have ankle huggers on.Provider states the fall caused user to break a bone in one of her feet but he was not aware as to which foot.

Manufacturer Narrative

The locking gas cylinders were returned.An expanded evaluation was completed and could not confirm the complaint.The cylinders did not have any performance defects which would cause them to make the drive wheel of the power wheelchair to remain in the air.There were no malfunctions observed during the functional testing of both cylinders.The dealer stated the cylinders were replaced approximately two weeks prior to the event.The dealer also stated the locking cylinders were adjusted properly while still having the issue.The expanded evaluation was not able to determine if the installation of the cylinders was out of adjustment causing them not to lock or compress properly due to the whole device not being returned.Should additional information become available, a supplemental record will be filed.

• Brand Name: TDXSP FOR FORMULA CG WITH MK6I
• Type of Device: WHEELCHAIR, POWERED
• Manufacturer (Section D): INVACARE TAYLOR ST.; 1200 taylor street; elyria OH 44036
• Manufacturer (Section G): INVACARE TAYLOR ST.; 1200 taylor st.; elyria OH 44036
• Manufacturer Contact: jason fiest ; one invacare way; elyria, OH 44036 ; 8003336900
• MDR Report Key: 6350218
• MDR Text Key: 68049288
• Report Number: 1525712-2017-00008
• 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
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 01/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: NA:TDXSP-CG
• Device Catalogue Number: TDXSP-CG
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2013
• 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 Outcome(s): Required Intervention