MAUDE Adverse Event Report: INVACARE TAYLOR STREET SOLARA 3G DEMO 2 W/70NTAPER 20 IN H MATRX ELITE DEEP BACK; WHEELCHAIR, MECHANICAL

Model Number SOLARA3G

Device Problems Bent (1059); Break (1069); Crack (1135)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Mdr is being submitted as a result of a retrospective complaint review.The suspect parts were returned for evaluation, and subsequent testing verified the complaint.The welds were broken.The underlying cause could not be determined after reviewing the documentation in this investigation.

Event Description

The dealer states the left weld broke above the top elevating support tube and also cracked/bent the sector leg rest support tube.

• Brand Name: SOLARA 3G DEMO 2 W/70NTAPER 20 IN H MATRX ELITE DEEP BACK
• Type of Device: WHEELCHAIR, MECHANICAL
• Manufacturer (Section D): INVACARE TAYLOR STREET; 1200 taylor street; elyria OH 44036
• Manufacturer (Section G): INVACARE TAYLOR STREET; 1200 taylor street; elyria OH 44036
• Manufacturer Contact: kevin guyton ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 5676203
• MDR Text Key: 45806821
• Report Number: 1525712-2016-01525
• 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
• Type of Report: Initial
• Report Date: 06/04/2012

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: SOLARA3G
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2012
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/04/2012
• Was Device Evaluated by Manufacturer?: Yes
• 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