MAUDE Adverse Event Report: TAYLOR STREET MANUFACTURING SOLARA TILT-IN-SPACE; WHEELCHAIR, MECHANICAL

Model Number NA:SOLARA2G

Device Problem Break (1069)

Patient Problem Death (1802)

Event Date 04/06/2017

Event Type  Death  

Manufacturer Narrative

The solara2g custom manual wheelchair has not been returned to invacare as of the date of this report.No further information was provided by the reporter.Should additional information become available, a supplemental record will be filed.

Event Description

Invacare was notified by a lawyer representing the family of the deceased.The lawsuit describes a fatal auto accident where the deceased was in a solara2g custom manual wheelchair that was tied down in a van.The lawsuit alleges frame weld failures, a defective design, manufacturing, and labeling.

• Brand Name: SOLARA TILT-IN-SPACE
• Type of Device: WHEELCHAIR, MECHANICAL
• Manufacturer (Section D): TAYLOR STREET MANUFACTURING; 1200 taylor street; elyria 44036
• Manufacturer (Section G): TAYLOR STREET MANUFACTURING; 1200 taylor street; elyria OH 44036
• Manufacturer Contact: jason fiest ; one invacare way; elyria 44035 ; 8003336900
• MDR Report Key: 7247571
• MDR Text Key: 99208552
• Report Number: 1525712-2018-00012
• 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: other
• Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date: 01/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: NA:SOLARA2G
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/11/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2009
• 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): Death