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

Model Number TREX20RFP

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 a supplemental record will be filed.

Event Description

The dealer stated the chair arrived with both seat rails bent out of box.

Manufacturer Narrative

Product was returned for evaluation.The return fields in oracle state: standard wheelchairs.Frame, bent frame.Both seat rails are bent won't fit h blocks both rear wheels the bearings are squeaking.Product received expanded evaluation.The expanded evaluation report states: visual inspection- the cross brace was in good condition, but the seat rails were bent such that they did not align with the h-blocks correctly.The seat upholstery sagged due to the bent seat rails.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 tracer ex2 wheelchair of having bent seat rails.Complaint of "seat rails bent " 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, bent frame.Both seat rails are bent won't fit h blocks both rear wheels the bearings are squeaking.Product received expanded evaluation.The expanded evaluation report states: visual inspection- the cross brace was in good condition, but the seat rails were bent such that they did not align with the h-blocks correctly.The seat upholstery sagged due to the bent seat rails.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 tracer ex2 wheelchair of having bent seat rails.The dealer stated the chair arrived with both seat rails bent 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: 5064529
• MDR Text Key: 25892519
• Report Number: 9616091-2015-02220
• 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: 11/13/2015

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: TREX20RFP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/13/2015
• Initial Date FDA Received: 09/09/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/03/2015
• 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
• Patient Outcome(s): Other