MAUDE Adverse Event Report: INVAMEX TREX2/WD86/ADULT/28/BH16/1255/U2222C/U67 9153653558; WHEELCHAIR, MECHANICAL

Model Number TREX28RP

Device Problems Bent (1059); Out-Of-Box Failure (2311)

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

Dealer states the frame was bent right out of the box which is causing the left wheel to rub against the frame.

Manufacturer Narrative

Product was returned for evaluation.The return fields in oracle state: standard wheelchairs.Assembly/component issue, rear wheel cracked/broken.Problem with right not left side right rear wheel out of round rubs right arm both arms have to much play.Product received expanded evaluation.The expanded evaluation report states: visual inspection- the right rear wheel was out of round and did not roll straight.As it rotated, it made contact with the arm rest and then moved 3/8 of an inch away from it.Functional observation- the wheels are free of debris and are able to roll freely, despite the right rear wheel being out of round.Conclusions- utilizing existing complaint information, actual observations, and functional testing of the returned product in its "as received" condition, the complaint was confirmed due to the right rear wheel being out of round.Complaint of "left wheel to rub against the frame" 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.Assembly/component issue, rear wheel cracked/broken.Problem with right not left side right rear wheel out of round rubs right arm both arms have to much play.Product received expanded evaluation.The expanded evaluation report states: visual inspection- the right rear wheel was out of round and did not roll straight.As it rotated, it made contact with the arm rest and then moved 3/8 of an inch away from it.Functional observation- the wheels are free of debris and are able to roll freely, despite the right rear wheel being out of round.Conclusions- utilizing existing complaint information, actual observations, and functional testing of the returned product in its "as received" condition, the complaint was confirmed due to the right rear wheel being out of round.Dealer states the frame was bent right out of the box which is causing the left wheel to rub against the frame.

• Brand Name: TREX2/WD86/ADULT/28/BH16/1255/U2222C/U67 9153653558
• 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: 5270500
• MDR Text Key: 33011252
• Report Number: 9616091-2015-02832
• 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: 12/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: TREX28RP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/16/2015
• 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