MAUDE Adverse Event Report: INVAMEX TRSX5/WD08/AD/28/34P/U240/1255/U2222/AHDRM/9691B/GVT93HC/G1360/BH16 9153649403; WHEELCHAIR, MECHANICAL

Model Number TRSX5

Device Problem Bent (1059)

Patient Problem Discomfort (2330)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The tbm called in stating that he visited one of his dealers that provided a trsx5 wheelchair to an end user that has a prior head injury.The tbm stated that the end user is really beating up the chair due to his prior injury.He stated that one of the back canes are bent and the frame is bent.No alleged injury.No additional information provided.Update from 1/15/16 provided by current therapy: dealer states that the unit pivot links have broken, the cross braces and the back cane have bent the clothing guards have snapped due to the bending and he has gotten pinched in the process.Dealer stated that the invacare sales rep saw the chair and states that the chair did not hold up to its weight capacity of 300lbs.Dealer provided a loaner for patient until new chair is ordered.

Manufacturer Narrative

Product was returned for evaluation.The return fields in oracle state: standard wheelchairs.Frame, crossbrace damage.Chair was torn down to pieces before returned.In very used condition for age.Pivot link bent on left side broken clothing guard on left side.Product received expanded evaluation.The expanded evaluation report states: utilizing existing complaint information, actual observations, and functional testing of the returned product in its "as received" condition, the complaint was not confirmed for the tracer sx5 wheelchair of having broken pivot links or a bent cross brace.It was confirmed that the wheelchair had one back cane, a fractured right clothing guard, one bent pivot link, and wear to both anti-tippers.Complaint 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, crossbrace damage.Chair was torn down to pieces before returned.In very used condition for age.Pivot link bent on left side broken clothing guard on left side.Product received expanded evaluation.The expanded evaluation report states: utilizing existing complaint information, actual observations, and functional testing of the returned product in its "as received" condition, the complaint was not confirmed for the tracer sx5 wheelchair of having broken pivot links or a bent cross brace.It was confirmed that the wheelchair had one back cane, a fractured right clothing guard, one bent pivot link, and wear to both anti-tippers.The tbm called in stating that he visited one of his dealers that provided a trsx5 wheelchair to an end user that has a prior head injury.The tbm stated that the end user is really beating up the chair due to his prior injury.He stated that one of the back canes are bent and the frame is bent.No alleged injury.No additional information provided.Update from (b)(4) 2016 provided by current therapy: dealer states that the unit pivot links have broken, the cross braces and the back cane have bent the clothing guards have snapped due to the bending and he has gotten pinched in the process.Dealer stated that the invacare sales rep saw the chair and states that the chair did not hold up to its weight capacity of 300lbs.Dealer provided a loaner for patient until new chair is ordered.

• Brand Name: TRSX5/WD08/AD/28/34P/U240/1255/U2222/AHDRM/9691B/GVT93HC/G1360/BH16 9153649403
• 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: 5387902
• MDR Text Key: 36773813
• Report Number: 9616091-2016-00106
• 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: company representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 02/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: TRSX5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/18/2016
• 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
• Patient Weight: 129