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

Model Number CXE

Device Problems Vibration (1674); Structural Problem (2506)

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

Event Type  malfunction  

Manufacturer Narrative

A follow up will be sent if the product or additional information is obtained.

Event Description

Dealer stated the fork assembly attachment holes were reamed causing caster flutter.

Manufacturer Narrative

Product was returned for evaluation.The return fields in oracle state: custom manual wheelchairs.Frame, head tube failure.Complaint was confirmed.The underlying cause could not be determined after reviewing the documentation in this investigation.

Event Description

Product was returned for evaluation.The return fields in oracle state: custom manual wheelchairs.Frame, head tube failure.Dealer stated the fork assembly attachment holes were reamed causing caster flutter.

• 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: 5100670
• MDR Text Key: 26839337
• Report Number: 1525712-2015-04642
• 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: Followup
• Report Date: 11/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: CXE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/16/2015
• 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