MAUDE Adverse Event Report: INVAMEX TRACER IV; WHEELCHAIR, MECHANICAL

Model Number T4X24RDA

Device Problem Detachment Of Device Component (1104)

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

Event Type  malfunction  

Manufacturer Narrative

It is unknown under what circumstances the hand grips became detached or if there was any patient involvement.Attempts have been made to contact the dealer for additional information without success.This t4x24rda wheelchair was manufactured in june 2009; therefore, the hand grips have exceeded their wear period of 1 year, and the entire chair has exceeded its expected life of 5 years.The tracer iv owner's manual states, "always check hand grips for looseness before using the wheelchair.If loose and/or worn, replace immediately." the safety inspection checklist within the owner's manual also instructs to inspect the back cane hand grips for wear/looseness/deterioration on a monthly basis and to replace if looseness or deterioration is found.Since the manufacture of this chair, an improvement to the design of the hand grip assemblies has been implemented which allows for increased adhesion to the back canes.Should additional information become available, a supplemental record will be filed.

Event Description

The dealer reported that the back cane hand grips are coming off on the t4x24rda wheelchair.

• Brand Name: TRACER IV
• Type of Device: WHEELCHAIR, MECHANICAL
• Manufacturer (Section D): INVAMEX; 102 parque industrial manimex; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer (Section G): INVAMEX; 102 parque industrial manimex; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: jason fiest ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 7269424
• MDR Text Key: 100136296
• Report Number: 9616091-2018-00004
• 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
• Report Date: 01/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: T4X24RDA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/15/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1