MAUDE Adverse Event Report: INVAMEX TILT IN SPACE; WHEELCHAIR, MECHANICAL

Model Number NA:SOLARA3G

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Abrasion (1689)

Event Type  Injury  

Event Description

A staff member had the patient out for a walk using a rea azalea wheelchair.When they stopped, the staff member thought they had applied the brake, but they only flicked the handles forward, using the brakes at the wheels.The chair then moved forward, and the front wheels went over the curb causing the patient to be thrown from the wheelchair.This resulted in significant bruising to her eyes, forehead, face, and hands.She has a possible fracture to her nose, (unconfirmed) a possible concussion, and significant grazing to the forehead.

Manufacturer Narrative

Invacare was made aware of an event that took place in france with a 9-month old rea azalea wheelchair.Invacare is filing this report because the solara 3g wheelchair made at invacare owned invamex and sold in the u.S.Has been determined to be similar in design to the rea azalea.The information we have is that the rea azalea wheelchair functioned as intended.The caregiver did not apply the brakes correctly causing the wheelchair to move forward.No malfunction alleged.Should additional information become available, a supplemental record will be filed.

• Brand Name: TILT IN SPACE
• Type of Device: WHEELCHAIR, MECHANICAL
• Manufacturer (Section D): INVAMEX; 102 parque industrial manimex; 102 parque industrial manimex; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer (Section G): INVAMEX; 102 parque industrial manimex; 102 parque industrial manimex; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: jason fiest ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 14619352
• MDR Text Key: 293450159
• Report Number: 9616091-2022-00007
• Device Sequence Number: 1
• Product Code: IOR
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: NA:SOLARA3G
• Device Catalogue Number: SOLARA3G
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other