MAUDE Adverse Event Report: INVAMEX TREX2/WD06/18/BH16/U2222C/ADULT/U67/1255 9153653553; WHEELCHAIR, MECHANICAL

Model Number TREX20RFP

Device Problems Mechanical Problem (1384); 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 a supplemental record will be filed.

Event Description

The dealer states that the patient is alleging that the wheel is hitting the frame out of box.

Manufacturer Narrative

Product was returned for evaluation.The return fields in oracle state: standard wheelchairs.Assembly/component issue, rear wheel cracked/broken.Rh rear wheel rubs arm.Product received expanded evaluation.The expanded evaluation report states: visual inspection- the right rear wheel was bent and did not roll straight.As it rotated, the wheel came less than 1/16 of an inch from the arm rest and then moved away as far as 1/8 of an inch.Functional observations- the wheels are free of debris and are able to roll easily.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 "wheel is hitting the frame out of box" 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.Rh rear wheel rubs arm.Product received expanded evaluation.The expanded evaluation report states: visual inspection- the right rear wheel was bent and did not roll straight.As it rotated, the wheel came less than 1/16 of an inch from the arm rest and then moved away as far as 1/8 of an inch.Functional observations- the wheels are free of debris and are able to roll easily.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.The dealer states that the patient is alleging that the wheel is hitting the frame out of box.

• Brand Name: TREX2/WD06/18/BH16/U2222C/ADULT/U67/1255 9153653553
• 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: 5158963
• MDR Text Key: 28643106
• Report Number: 9616091-2015-02514
• 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

• Date FDA Received: 10/19/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: TREX20RFP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/04/2015
• 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