MAUDE Adverse Event Report: INVAMEX 9000 TOPAZ WHEELCHAIR; MECHANICAL (MANUAL) WHEELCHAIR

Model Number NA:9TPZ

Device Problem Device Slipped (1584)

Patient Problem Bone Fracture(s) (1870)

Event Date 06/22/2017

Event Type  Injury  

Manufacturer Narrative

A return authorization has been issued for the topaz wheelchair.It has not been returned at the time of filing this record.The facility alleged they did not make any adjustments to the chair.They could not provide any other information about the wheel lock function, positioning and if they could be rotated by hand since the wheelchair had already been packaged and shipped.The topaz was purchased to replace the patient's old chair.The end user stated that she liked the topaz and that it was more comfortable.The topaz is only used inside the facility.She uses different chairs for outside of the facility and bathroom use.The end user has a boot on her foot for the fracture.

Event Description

The dealer stated that on (b)(4) 2017, the equipment & maintenance coordinator of the facility called to report an incident that allegedly involved a 9000 topaz wheelchair.She reported that the resident was by herself and thought the brakes were on but they were not.She said the position of the brake was rotating and it is not supped to do that.When the resident got up, she fell because the brakes were not actually locked.This was the same for the both the left and right brakes.The end user was allegedly injured with a hairline fracture on her left ankle.The maintenance coordinator reported that the injured party was treated at a hospital/clinic and released.The product has been taken out of use.And she said that at the time of the incident, there were no other people present.

Manufacturer Narrative

The topaz wheelchair was returned and an expanded evaluation was completed.The alleged issue was with both wheel locks not engaging the rear wheels, but in their returned orientation the issue could only be confirmed on the left wheel lock.The left wheel lock was found to be rotated downward, causing the rear wheel not to be engaged allowing the chair to move during transfer.The right wheel lock was found to be capable of engaging the right rear wheel and preventing its rotation.The user manual included with this device advises the user to ¿always exercise caution when transferring into or out of the wheelchair¿ and ¿before attempting to transfer in or out of the wheelchair, be certain the wheel locks are engaged to help prevent the wheels from moving¿.

• Brand Name: 9000 TOPAZ WHEELCHAIR
• Type of Device: MECHANICAL (MANUAL) WHEELCHAIR
• Manufacturer (Section D): INVAMEX; parque industrial manimex; reynosa, tamaulipas
• Manufacturer (Section G): INVAMEX; parque industrial manimex; reynosa, tamaulipas
• Manufacturer Contact: jason fiest ; one invacare way; elyria, OH 44036 ; 8003336900
• MDR Report Key: 6733555
• MDR Text Key: 80700990
• Report Number: 9616091-2017-00005
• Device Sequence Number: 1
• Product Code: IOR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 06/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: NA:9TPZ
• Device Catalogue Number: 9TPZ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Weight: 136