MAUDE Adverse Event Report: INVAMEX 9XT SWINGAWAY FRAME STYLE 9153629153; WHEELCHAIR, MECHANICAL

Model Number 9XT

Device Problem Break (1069)

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

Event Type  malfunction  

Event Description

Dealer states the cross brace broke on this chair where the bolt goes through.No injury reported.

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.

Manufacturer Narrative

A returned was issued and the product was evaluated upon receipt.The complaint was confirmed for the cross brace to be broken through the tubing at the center bolt.

Event Description

Dealer states the cross brace broke on this chair where the bolt goes through.No injury reported.

• Brand Name: 9XT SWINGAWAY FRAME STYLE 9153629153
• 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: 4901141
• MDR Text Key: 22244499
• Report Number: 9616091-2015-01793
• 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,distributor
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 08/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 9XT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/03/2015
• 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
• Patient Outcome(s): Other