MAUDE Adverse Event Report: INVACARE TAYLOR STREET SOLARA 3G DEMO 3 LOW SHEAR RECLINE/20 IN H MATRX PB BACK; WHEELCHAIR, MECHANICAL

Model Number SOLARA3G

Device Problems Break (1069); Device Tipped Over (2589)

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

Event Date 07/13/2015

Event Type  malfunction  

Manufacturer Narrative

A returned was issued and the product is awaiting receipt and/or evaluation.A follow up will be filed if/when any additional information is provided.

Event Description

Dealer advised frame is broken at a weld on both sides on the back of the chair.Dealer advised chair tipped forward with end user in chair but enduser did not fall.

• Brand Name: SOLARA 3G DEMO 3 LOW SHEAR RECLINE/20 IN H MATRX PB 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: 4973482
• MDR Text Key: 23461647
• Report Number: 1525712-2015-04170
• 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
• Report Date: 07/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/05/2015
• 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