Medical Device Field Correction Update – June 2010

POTENTIALLY AFFECTED MODELS:
Motion Concepts TRx Tilt/ Elevating Seating Systems & TRx Tilt/ Recline/ Elevating Seating Systems. (Elevate-Only Systems are not affected)
Note: Potentially affected models are distinguishable by a round elevating actuator design.

Units manufactured/ distributed between February 1, 2001 and June 29, 2007.

AFFECTED SERIAL NUMBERS:
Potentially affected system serial numbers range from MC006176 to MC024718
Note: not all serial numbers within this range are affected

Date Recall Launched: March 2009

Motion Concepts initiated recall for its TRx Tilt/ Elevating Seating Systems and TRx Tilt/ Recline/ Elevating Seating Systems As part of our ongoing evaluation of product returns and on-going testing, Motion Concepts has identified the possibility of stress related cracks occurring in our power elevating seat (PES) actuator models as a result of atypical or extreme usage of the wheelchair seating system. The cracking may occur in the aluminum upper riser assembly of the PES actuator tower, along the weld between the top plate (which mounts to the main seating system) and the aluminum splined shaft.

While our risk analysis model and our test results indicate that the likelihood of this type of weld failure is deemed to be very low under typical operating conditions, our findings have also revealed that during extreme testing, this particular failure progresses gradually (by way of weld fatigue), and typically provides perceptible indicators/ evidence over the course of several weeks or months that a failure may be imminent. Our investigation has shown that for those actuators that indeed failed, either the wheelchair was being used in a manner not consistent with its labeling or the end user detected something was “not right” with their wheelchair, but a proper dealer inspection/ corrective action was not conducted.

The following indicators may be exhibited as early evidence of weld fatigue in the PES actuator tower, and should necessitate an inspection by an authorized Dealer:

• Sloppiness or a sensation that the system is unstable when elevated/ when tilted/ when driving

• Unusual/ unidentified creaking or grinding noises emitted from the wheelchair seat and/or PES actuator.

• Recent replacement or adjustments or to the elevating microswitch. Was the microswitch damaged (crushed/ bent)?

• Unusual or intermittent issues with the drive lockout (DLO) or reduced drive function.

• A significant change from the original pre-tilt angle of the seating system.

IF CRACKING OCCURS, THE ACTUATOR MAY FAIL AND THE USER COULD SUFFER SERIOUS INJURIES (I.E. BROKEN BONES, LACERATIONS) OR DEATH.

Motion Concepts has chosen to initiate this recall notice to ensure that this important information is provided to those who need it, and make certain that the recommended corrective action is performed as necessary to mitigate any possible risk.

If your wheelchair seating system displays any of the aforementioned indicators and/or meets the criteria of a potentially affected unit noted above, a physical inspection of the seating system by your service provider should be arranged immediately to confirm if a replacement actuator is required, and ensure your personal safety. If an inspection reveals the presence of weld fatigue or cracking as described, Motion Concepts instructs that use of the product be discontinued until appropriate product service can be obtained.

For any inspection that reveals any evidence of weld fatigue, cracking or related damage to the PES actuator, Motion Concepts will provide a no charge replacement PES actuator as part of a complete replacement kit. The replacement PES actuator design utilizes an all steel upper riser assembly (with resistance to cracking) in place of the previous aluminum construction.

If for some reason you currently do not have a provider, or if your provider is unable to correct your device, contact Motion Concepts as shown below so we can assist you in getting your device properly inspected.

United States Canada   Motion Concepts USA 700 Ensminger Rd. Suite 112 Tonawanda, NY 14150 USA Motion Concepts Canada 84 Citation Drive Concord, ON L4K 3C1 Canada Toll Free Tel: 1.888.433.6818 Toll Free Fax: 1.888.433.6834 Toll Free Tel: 1.866.748.7943 Fax: 905-695-0583 Recall Coordinator: info@motionconcepts.com