MAUDE Adverse Event Report: INVAMEX T4/WD28/HD/ADULT/18/BH16/AT903/U2222C/U67 9153653569; WHEELCHAIR, MECHANICAL

Model Number T4X22RDA

Device Problem Break (1069)

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 states that the right rear frame broke at the weld.

Manufacturer Narrative

Product was returned for evaluation.The return fields in oracle state: standard wheelchairs.Frame, broken frame/weld.Product received expanded evaluation.The expanded evaluation report states: utilizing existing complaint information, actual observations, and functional testing of the returned product in its "as received" condition, the complaint was confirmed with respect to the alleged issue.The weld between the back cane and the lower sidebar of the right side frame that was returned was broken.The same weld was intact on the left side frame that was returned, but exhibited noticeable signs of wear.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: standard wheelchairs.Frame, broken frame/weld.Product received expanded evaluation.The expanded evaluation report states: utilizing existing complaint information, actual observations, and functional testing of the returned product in its "as received" condition, the complaint was confirmed with respect to the alleged issue.The weld between the back cane and the lower sidebar of the right side frame that was returned was broken.The same weld was intact on the left side frame that was returned, but exhibited noticeable signs of wear.The dealer states that the right rear frame broke at the weld.

• Brand Name: T4/WD28/HD/ADULT/18/BH16/AT903/U2222C/U67 9153653569
• 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: 5396117
• MDR Text Key: 37011641
• Report Number: 9616091-2016-00135
• 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: Initial,Followup
• Report Date: 02/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: T4X22RDA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/26/2016
• 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