MAUDE Adverse Event Report: INVACARE CORPORATION POWERED WHEELCAHIR SYSTEM; WHEELCHAIR

Model Number	INVACARE RX BASE
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Codes	Bruise/Contusion (1754); Laceration(s) (1946)
Date of Event	03/23/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
On march 28, 2025, medbloc (distributor) notified motion concepts lp of an incident involving one of our wheelchairs.The unit had been sold to an end-user in the united states via the dealer access medical in kawaihae, hawaii, who is also responsible for its maintenance.The end-user had been in communication with the base manufacturer, invacare, to share feedback and concerns regarding the functionality of the wheelchair base.During this interaction, the end-user reported an incident in which the wheelchair unexpectedly veered to one side while he was reversing near his bathroom sink.As a result, his arm became trapped between the wheelchair's armrest and the sink, causing a cut and significant bruising.At the time of the incident, the system had been in use for approximately eight months.
Additional Manufacturer Narrative
The mentioned system was shipped from motion concepts to medbloc (motion concepts usa importer/distributor), as per dealer requirements, on 25-jul-2024.The system was subsequently sold to the access medical in kawaihae, hawaii on august 02, 2024.The reported base was manufactured by a third-party manufacturer.The manufacturer has been informed of this incident by our distributor.To address the incident, motion concepts has decided to replace the alleged base with a new base (serial number: (b)(6), which was shipped on 04-apr-2025.The dealer will be responsible for transferring the existing seating system to the new base.We have also advised them to contact us should any issues arise during the transfer process.This incident was caused by a malfunction of a third-party manufactured product, not a motion concepts product.Since personal injury was involved, we consider this incident reportable.

• Brand Name: POWERED WHEELCAHIR SYSTEM
• Common Device Name: WHEELCHAIR
• Manufacturer (Section D): INVACARE CORPORATION; 1200 taylor street; elyria OH 44035
• Manufacturer (Section G): INVACARE CORPORATION; 1200 taylor street; elyria OH 44035
• Manufacturer Contact: ronald tucker ; 1200 taylor street; elyria, OH 44035 ; 4403296284
• MDR Report Key: 21895427
• Report Number: 9615350-2025-00003
• Device Sequence Number: 3443034
• Product Code: ITI
• UDI-Device Identifier: 00841447114581
• UDI-Public: 00841447114581
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K202379
• 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: Replace
• Type of Report: Initial
• Report Date (Section B): 04/23/2025

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: INVACARE RX BASE
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/25/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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: Male