MAUDE Adverse Event Report: INVAMEX TREX2/WD66/ADULT/28/U550 9153637773; WHEELCHAIR, MECHANICAL

Model Number TREX2

Device Problems Bent (1059); Mechanical Problem (1384); Unstable (1667)

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

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Customer states that the chair is defective and the chair has a bend in the frame of the chair.The right wheels wobble and appear to be bent.In some cases they rub the side of the chair.Per the technician's evaluation, the frame does not seem to be bent.The wheel is bent causing the wobble and the arms do have excessive play in them allowing the wheels to rub on them.

Manufacturer Narrative

Product received expanded evaluation.The expanded evaluation report states: visual inspection- the wheelchair was clean and without any scratches, dents, or broken welds.The right rear wheel was bent and did not roll straight.As it rotated, the wheel touched the arm rest and then moved as far away as 3/16 of an inch.Functional observations- the wheels are free of debris and are able to roll easily, despite the right rear wheel touching the arm rest.Conclusions- utilizing existing complaint information, actual observations, and functional testing of the returned product in its "as received" condition, the complaint was confirmed for the bent right rear wheel.Complaint of "bend in the frame of the chair" was not confirmed.Complaint of "right wheels wobble and appear to be bent" was confirmed.The underlying cause could not be determined after reviewing the documentation in this investigation.

Event Description

Customer states that the chair is defective and the chair has a bend in the frame of the chair.The right wheels wobble and appear to be bent.In some cases, they rub the side of the chair.Per the technician's evaluation, the frame does not seem to be bent.The wheel is bent causing the wobble and the arms do have excessive play in them allowing the wheels to rub on them.

• Brand Name: TREX2/WD66/ADULT/28/U550 9153637773
• 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: 5184507
• MDR Text Key: 30078456
• Report Number: 9616091-2015-02597
• 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: 11/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: TREX2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/07/2015
• Initial Date FDA Received: 10/28/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/12/2015
• 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