MAUDE Adverse Event Report: MOTION CONCEPTS LP POWERED WHEELCHAIR SYSTEM

Model Number INVA/MATRX MX2 BACK FITS W:16", H:12" W/QUICK RELEASE HDWR

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Fall (1848)

Event Date 08/01/2020

Event Type  malfunction  

Manufacturer Narrative

The mentioned invacare-matrx mx2 back was shipped from motion concepts to medbloc ((b)(4) importer/distributor), as per dealer requirements, on 24-oct-2019 and then was sold to hudson seating & mobility, ma on 25-oct-2019.The dealer reported that the end user was using his third-party manual wheelchair and when he tried to lean backwards, the right-side backrest mounting hardware broke causing him to fall backwards by hitting his head.The dealer also stated that there was no medical attention needed for the end user.The mentioned back and hardware were manufactured by motion concepts but was installed on a third-party manual wheelchair by the dealer.After evaluating the incident based on the information and picture provided by the dealer, it was determined that the mounting hardware was broken possibly due to the back was installed un-symmetrically, as the left side was tilted backwards and right side is tilted forward.So, we cannot confirm if the installation was done as per provided installation instructions.During the evaluation, it was also determined that the failure of the right-side mounting hardware was in fact not sudden, but gradual and as the left side mounting hardware has not failed, the only possible way upsetting the end-user balance which caused him to fall down was that the left-side mounting hardware was not tightened properly.Motion concepts have included warning statements on the user manuals for avoiding incidents similar to this.In the care and maintenance section of the matrx mx2 back installation user manual, it has been stated that: "monthly: perform a visual inspection of parts including hardware, brackets, upholstery materials, foams, and plastics for deformation, corrosion, breakage, wear or compression.Warning! risk of injury or damage: inspect all fasteners weekly to ensure that mechanical connections and attaching hardware are tightened securely.Do not continue to use this product if problems are discovered.Corrective measures can be performed at or arranged through your equipment supplier." to address this incident, the manual wheelchair was reworked/serviced by the dealer on 29-oct-2020.

Event Description

On 16-oct-2020, motion concepts lp was notified by medbloc inc.((b)(4) importer), that one of their dealers (hudson seating & mobility) informed them of an incident that took place on (b)(6) 2020.The dealer reported that the end user was using his third-party manual wheelchair and when he tried to lean backwards, the backrest mounting hardware ((b)(4) product) broke causing him to fall backwards by hitting his head.The dealer also stated that there was no medical attention needed for the end user.

• Brand Name: POWERED WHEELCHAIR SYSTEM
• Type of Device: WHEELCHAIR
• Manufacturer (Section D): MOTION CONCEPTS LP; unit 1-12; 84 citation drive; concord, on L4K 3 C1; CA L4K 3C1
• Manufacturer (Section G): MOTION CONCPETS LP; unit 1-12; 84 citation drive; concord, on L4K 3 C1; CA L4K 3C1
• Manufacturer Contact: dona bhamra ; unit 1-12; 84 citation drive; concord, on L4K 3-C1 ; CA L4K 3C1
• MDR Report Key: 10801376
• MDR Text Key: 246503008
• Report Number: 9615350-2020-00010
• Device Sequence Number: 1
• Product Code: ITI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• 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
• Report Date: 11/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: INVA/MATRX MX2 BACK FITS W:16", H:12" W/QUICK RELEASE HDWR
• Device Catalogue Number: IMX21612-QRH
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/24/2019
• 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 Age: 26 YR
• Patient Weight: 59