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

Model Number 9XT

Device Problems Break (1069); Compatibility Problem (2960)

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

Event Type  malfunction  

Manufacturer Narrative

A returned was issued and the product was evaluated upon receipt.Complaint confirmed for the seat to floor height was 13.5 inches, not the expected 14.5 inches.The root cause was a broken weld at the right headtube due to a manufacturing defect.

Event Description

Dealer states that the seat to floor height does not measure 14.5 inches.The caster is also broken.

Manufacturer Narrative

(b)(6) - the device was returned for an evaluation.That evaluation determined that the complaint was confirmed for the seat-to-floor height not measuring 14 1/2 inches, the headtube having a broken weld, and the side frame having the incorrect number of axle lugs.Any underlying cause of these issues was not able to be identified.

Event Description

Dealer states that the seat to floor height does not measure 14.5 inches.The caster is also broken.

• 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: 5050655
• MDR Text Key: 25417770
• Report Number: 9616091-2015-02181
• 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: 09/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2015
• 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: 09/08/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/08/2015
• 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