MAUDE Adverse Event Report: MOTION CONCEPTS LP POWERED WHEELCHAIR SYSTEM

Model Number BPPS-T

Device Problem Unintended System Motion (1430)

Patient Problem Bruise/Contusion (1754)

Event Date 03/04/2022

Event Type  malfunction  

Manufacturer Narrative

The identified system was shipped from motion concepts to medbloc (motion concepts usa importer/distributor), as per dealer requirements, on 29-jul-2019 and then was sold to fonte surgical supply, rochester, ny on 09-aug-2019.To date, the incident information received by motion concepts is limited to what has been reported by the dealer (fonte surgical supply).The dealer stated that (b)(6) 2022, the system began to tilt on its own while the end user was seated in the wheelchair.The end user attempted to turn off the tilting function without success.As the system tilted, the end user's legs collided with a countertop causing bruising to both legs and both shins.The identified wheelchair system was 32 months old and was being maintained by the fonte surgical supply.The wheelchair distributor (medbloc) has also reported that the dealer, fonte surgical supply, will be conducting the repair for the wheelchair.On 22-mar-2022, motion concepts has issued a request to have the alleged defective part(s) returned for our evaluation.As of the date of this initial response, the returning part(s) have not been received at motion concepts.At this time, we are unable to identify or confirm the root cause of this incident.Upon receipt of the returning part(s) and completion of our investigation/evaluation, a follow-up report will be issued to the fda.As a personal injury was involved, motion concepts does consider this incident to be reportable.

Event Description

On 21-mar-2022, motion concepts lp was notified by medbloc inc.(motion concepts importer), that one of their dealers (fonte surgical supply, rochester, ny) informed them of an incident that took place on (b)(6) 2022.The dealer reported that, the system started to tilt on it own, while the end user was sitting on the wheelchair.The end user tried to turn off the tilting mechanism but had no success.The end user got hit on the countertop, causing bruising on the shins and legs on both sides.

Manufacturer Narrative

This is a follow up report on mdr 9615350-2022-00002, which was submitted to the fda on 31-mar-2022.At the time of the original submission, the alleged defective part (p.N - tre0748) had not yet been received by motion concepts for evaluation.Motion concepts received the alleged defective part on 13-jun-2022, and the device was subsequently forwarded to the third-party manufacturer for investigation/evaluation.Following their investigation, the device manufacturer informed motion concepts that the returned device was not functioning as intended.During the evaluation testing by the device manufacturer, it was determined that the 'save' & 'exit' buttons on the device had no response.Upon closer evaluation of the returned device, the protective overlay on the surface of the device showed evidence of damaged or may have been lifted or tampered with, which would effectively compromise the seal between the device housing and the internal components.When the device manufacturer disassembled the device, there were visible traces of corrosion to the internal components, including the affected [?]save' and [?]exit' buttons.The device manufacturer concluded that the reported functional error in the device was caused by corrosion, as a result of extended exposure to environmental conditions, which was initiated by damage or tampering to the protective overlay on the device housing by the end user/dealer.Service history on the device determined that the wheelchair system was 32 months old at the time of the reported issue.No other service issues were reported during this time frame and there was no previous history of malfunction reported.Based on the information provided by the device manufacturer, motion concepts has concluded that the reported issue was caused by extended exposure to environmental conditions due to a physically compromised or damaged seal with the protective overlay.The compromised seal ultimately resulted in corrosion to the internal components of the device, which in turn caused the device to no longer function as intended.

• Brand Name: POWERED WHEELCHAIR SYSTEM
• Type of Device: WHEELCHAIR
• Manufacturer (Section D): MOTION CONCEPTS LP; 84 citation drive; unit 1-12; concord, ontario L4K 3 C1; CA L4K 3C1
• Manufacturer (Section G): MOTION CONCEPTS LP; 84 citation drive; 84 citation drive; 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: 13971057
• MDR Text Key: 293342111
• Report Number: 9615350-2022-00002
• Device Sequence Number: 1
• Product Code: ITI
• UDI-Device Identifier: 07540147011406
• UDI-Public: 07540147011406
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K182995
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 07/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: BPPS-T
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 06/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/29/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female
• Patient Weight: 147 KG