MAUDE Adverse Event Report: INVAMEX T4/WD28/HD/ADULT/18/BH16/AT903/U2222C/U67 9153653569; WHEELCHAIR, MECHANICAL

Model Number T4X24RDAP

Device Problem Mechanical Problem (1384)

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

Provider states the chair tilts to one side, does not sit level on the ground.

Manufacturer Narrative

Additional/updated information was added to reflect the device being returned to the manufacturer for evaluation, and subsequent testing verified the complaint.The underlying cause could not be determined after reviewing the documentation in this investigation.Per the initial evaluation, the left front caster three-wheels and does not touch the surface of the ground.An expanded evaluation was performed.Per the expanded evaluation report, the left side of the wheelchair was slightly raised so that the left caster did not touch the ground, and the left side frame appeared to be slightly uneven.When the chair was pushed forward, it would lean slightly downward on the left side.

Event Description

Provider states the chair tilts to one side, does not sit level on the ground.

• Brand Name: T4/WD28/HD/ADULT/18/BH16/AT903/U2222C/U67 9153653569
• 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: 5349945
• MDR Text Key: 35252592
• Report Number: 9616091-2016-00014
• 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: 01/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: T4X24RDAP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/12/2016
• 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