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

Dealer is stating that right cane is separated from the bottom rail at the weld.

Manufacturer Narrative

Additional/updated information was added to reflect the device 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, the tubing/weld was broken at the lower rear of the right side frame.An expanded evaluation was performed.The expanded evaluation report confirmed that the ride side frame was broken at the weld between the right back cane and the lower side bar, near where the right wheel attaches to the side frame.The break went completely around the back cane weld.This made the chair somewhat wobbly while in motion but did not seem to affect the functionality of the chair.Additionally, the upper left of the back upholstery was partially torn near the left back cane, and the tear was covered with tape.

Event Description

Dealer is stating that right cane is separated from the bottom rail 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: 5369398
• MDR Text Key: 36087077
• Report Number: 9616091-2016-00064
• 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: 02/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2016
• 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: 02/01/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/01/2016
• 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