MAUDE Adverse Event Report: INVAMEX 9XT SWINGAWAY FRAME STYLE 9153633131; WHEELCHAIR, MECHANICAL

Model Number 9XDT

Device Problems Device Operates Differently Than Expected (2913); Positioning Problem (3009)

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 product was returned to invacare (b)(4) and was confirmed to be defective; however, the specific defect is unknown.The underlying cause of the complaint issue could not be determined after reviewing the documentation in this investigation.

Event Description

The head tubes appear to not be welded on straight and inline with the rest of the frame.

• Brand Name: 9XT SWINGAWAY FRAME STYLE 9153633131
• Type of Device: WHEELCHAIR, MECHANICAL
• Manufacturer (Section D): INVAMEX; parque industrial manimex; reynosa 88780 ; MX 88780
• Manufacturer (Section G): INVAMEX; parque industrial manimex; reynosa 88780 ; MX 88780
• Manufacturer Contact: kevin guyton ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 5675704
• MDR Text Key: 45790736
• Report Number: 9616091-2016-00720
• Device Sequence Number: 1
• Product Code: IOR
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 02/02/2012

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: 9XDT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2012
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/02/2012
• 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