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 Bent (1059); Device Tipped Over (2589)

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

Event Date 02/23/2015

Event Type  malfunction  

Event Description

Provider states the forks are bending, enduser is tipping at the front edge of seat pan and the enduser is almost at the weight capacity and the seat pan is at the depth limit and the seat pan cannot be adjusted.No property damage or injury alleged.No further information provided.

• 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 FLORIDA OPERATIONS; 2101 east lake mary blvd; sanford FL 32773
• Manufacturer Contact: kevin guyton ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 4561618
• MDR Text Key: 17630699
• Report Number: 1525712-2015-01548
• 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: 02/23/2015

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: 02/20/2015
• Initial Date FDA Received: 03/03/2015
• 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