MAUDE Adverse Event Report: MOTION CONCEPTS N/A

Model Number	50T-RESR-MAXX
Medical Device Problem Codes	Misassembled (1398); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Inflammation (1932)
Date of Event	10/03/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The mentioned system was shipped from motion concepts to medbloc (motion concepts usa importer/distributor), on (b)(6) 2022 in accordance with dealer specifications.Subsequently, the aforementioned system was sold to numotion, located in (b)(6) on (b)(6) 2022.Upon receiving notification of the incident, we promptly initiated communication with the dealer, requesting the return of the wheelchair for a comprehensive evaluation.Regrettably, we have not yet received the system for evaluation, although the dealer has conveyed their assurance that the system will be returned to us in the imminent days.Based on our preliminary review of the provided details, it appears that the issue is related to the aviva rx base, a product originating from the base manufacturer, invacare.It is important to note that the alleged wheelchair uses motion concepts seating system, contributing to our decision to classify this incident as reportable.Subsequent to the system's return and the completion of our comprehensive evaluation, we intend to compile a follow-up report, which will be submitted to the fda.
Event or Problem Description
On (b)(6) 2023, motion concepts lp received a postal mail from an end-user reporting issues with their wheelchair and dissatisfaction with dealer customer service (numotion, taunton, ma).The reported malfunction involves the wheelchair momentarily pausing during turns and then abruptly releasing, resulting in collisions with furniture and walls.This erratic motion caused an injury to the user's foot, leading to swelling and subsequent bedrest for some days.Fortunately, x-rays confirmed no fractures, and the user reverted to their previous wheelchair due to safety concerns.The user also noted inadequate spinal support in the previous wheelchair, impacting her breathing.The correspondence also documented the wheelchair's repair history and dealer interactions.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
The system was returned on august 15, 2023, and underwent an evaluation for the reported issues.During the evaluation, it became evident that the system had undergone modifications after the chair was originally delivered by motion concepts to the dealer.Specifically, it was observed that someone had altered the footplate and adjusted the front rigging rearward.As a result, when the tilt module was in its home position (horizontal to the ground), the footplate now interfered with the casters, causing them not to pivot correctly.Following a thorough evaluation, we have concluded that the reported wheelchair malfunction during turning, which led to the incident, was directly attributed to the aforementioned modification.The interference of the footplate with the wheels disrupted the proper pivoting function, leading to abrupt releases.It's worth noting that both the safety information section and the general set-up & maintenance section of the motion concepts mpps owner's manual explicitly state: 'important! motion concepts disclaims all responsibility and liability for any personal injury or damage to property that occurs as a result of improper or insufficient maintenance, and/or any unauthorized dealer or unqualified third-party repairs or modifications made to the power positioning system or the wheelchair on which the system is installed.'.

• Brand Name: N/A
• Common Device Name: N/A
• Manufacturer (Section D): MOTION CONCEPTS; 84 citation drive; unit 1-12; concord, ontario L4K 3 C1; CA L4K 3C1
• Manufacturer (Section G): MOTION CONCEPTS LP; 84 citation drive; unit 1 -12; concord, ontario L4K 3 C1; CA L4K 3C1
• Manufacturer Contact: dona bhamra ; 84 citation drive; unit 1 -12; concord, ontario L4K 3-C1 ; CA L4K 3C1
• MDR Report Key: 17500229
• Report Number: 9615350-2023-00002
• Device Sequence Number: 11345898
• Product Code: ITI
• UDI-Device Identifier: 00754014710393
• UDI-Public: 00754014710393
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K150574
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Modification/Adjustment
• Type of Report: Initial,Followup
• Report Date (Section B): 09/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 50T-RESR-MAXX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/10/2023
• Supplement Report FDA Received Date: 09/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/09/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Weight: 91 KG