MAUDE Adverse Event Report: INVAMEX TRACER TRANSPORT CHAIR 19 X 16 9153647029; WHEELCHAIR, MECHANICAL

Model Number TRSX5RC

Device Problem Bent (1059)

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

Event Type  malfunction  

Manufacturer Narrative

A return was issued and the product is awaiting receipt and/or evaluation. a follow up will be filed if/when any additional information is provided.

Event Description

The customer stated that the frame is bent.

Manufacturer Narrative

Additional/updated information was added to reflect the device being returned to the manufacturer for evaluation, and subsequent testing verified the complaint.Per the initial evaluation, the frame was bent so that the top push bar would not align, and the chair also veered to the right.An expanded evaluation was performed.The expanded evaluation report confirmed that the right hand grip was slightly bent, so the spreader bar was unable to fit properly.However, the underlying cause could not be determined after reviewing the documentation in this investigation.The spreader bar is an option that can be used to push the wheelchair.It does not affect the stability or support of the end user.There is no allegation of a serious injury or death and the malfunction reported is not likely to cause a death or serious injury; therefore, this is not an fda reportable event.

Event Description

The customer stated that the frame is bent.

• Brand Name: TRACER TRANSPORT CHAIR 19 X 16 9153647029
• 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: 5758396
• MDR Text Key: 48466957
• Report Number: 9616091-2016-01050
• 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
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 07/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: TRSX5RC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/19/2016
• 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