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

Model Number 9XT

Device Problem Bent (1059)

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

Event Type  malfunction  

Manufacturer Narrative

Should additional information become available a supplemental record will be filed.

Event Description

The dealer stated that both crossbraces on the chair are bent.The dealer is not sure how the crossbraces got bent on the chair.

Manufacturer Narrative

Additional/updated information was added to reflect the cross braces being returned to the manufacturer for evaluation, and subsequent testing verified the complaint.However, the underlying cause could not be determined.Per the initial evaluation, both cross braces were bent at the seat rail.An expanded evaluation was performed.Per the expanded evaluation report, after a straight edge was placed against the edge of the seat rail, it was observed that one of the cross braces had a bent seat rail while the other did not appear to be bent.

Event Description

The dealer stated that both crossbraces on the chair are bent.The dealer is not sure how the crossbraces got bent on the chair.

• 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: 5836252
• MDR Text Key: 50860527
• Report Number: 9616091-2016-01132
• 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
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 09/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2016
• 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: 09/27/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/27/2016
• 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 Weight: 39