MAUDE Adverse Event Report: MOTION CONCEPTS LP POWERED WHEELCHAIR SYSTEM

Model Number 45T-12L-RESR-MAXX

Device Problem Device Difficult to Maintain (3134)

Patient Problem Pressure Sores (2326)

Event Date 04/20/2022

Event Type  Injury  

Manufacturer Narrative

The mentioned system was shipped from motion concepts to medbloc (motion concepts usa importer/distributor), as per dealer requirements, on 16-jan-2017 and then was sold to va medical center, milwaukee, wi on 17-jan-2017.The dealer reported that the end-user got sores in the calves caused due to the use of worn-out calf pads.The dealer also confirmed that there was no serious injury, and no medical treatment was needed by the end-user due to this incident.During the evaluation, it was also determined that the worn-out calf pad was in fact not sudden, but gradual as the reported system was 64 months old, and the calf pads of the system has never been changed or upgraded until this incident.So, this should have been caught by the dealer while they were processing the bi-annual maintenance on the reported system.Motion concepts have included warning statements on the owner's manuals for avoiding incidents similar to this.In the safety information section and also on the general set-up and maintenance section of the motion concepts mpps owner's manual, it has been stated that: "warning! risk of injury, damage and loss of warranty if proper maintenance is not followed.For reasons of safety and in order to avoid potential injury or damage from unnoticed wear, it is recommended that under normal operating conditions your power positioning system undergoes a complete a minimum bi-annual inspection." to address this incident, the replacement calf pads will be sent to the dealer and repair will be completed by the dealer.As a personal injury was involved, motion concepts does consider this incident to be reportable.

Event Description

On 20-apr-2022, motion concepts lp was notified by invacare cooperation, that one of the dealers in usa (va medical center, milwaukee, wi) informed them of an incident that was related to a motion concepts wheelchair.The dealer reported that the end user got sores on his calves due to the use of worn-out calf pads.The dealer also confirmed that there was no need for any medical treatment as it was not open sores and the end-user was just not comfortable with the situation.

• 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 Contact: 84 citation drive; unit 1 -12; concord, ontario L4K 3-C1
• MDR Report Key: 14601269
• MDR Text Key: 293341994
• Report Number: 9615350-2022-00003
• Device Sequence Number: 1
• Product Code: ITI
• UDI-Device Identifier: 00754014710065
• UDI-Public: 00754014710065
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150574
• 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: 06/06/2022

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
• Device Operator: Lay User/Patient
• Device Model Number: 45T-12L-RESR-MAXX
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/16/2017
• 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: Male
• Patient Weight: 86 KG