MAUDE Adverse Event Report: INVACARE TAYLOR STREET POWER CHAIR 20 WIDE BY 18 DEEP FOR PMI; WHEELCHAIR, POWERED

Model Number TDXSIV-HD

Device Problems Device Slipped (1584); Material Deformation (2976)

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 provider states both motor brakes appear to be stripped out and they are not stopping the chair.

Manufacturer Narrative

The tdxsiv-hd motors were returned for evaluation, and subsequent testing verified the complaint.Per the initial evaluation, the brake assemblies were loose and the left motor was leaking grease.An expanded evaluation was performed on the left motor.The expanded evaluation report confirmed that the left motor and gearbox of having the brake not engage after the inductive of the joystick returned to neutral.It was observed that there were three screws that were unfastened during disassembly of the brake.It is undetermined whether these screws unfastened during normal use of the device or if there was outside intervention that adulterated the device.The underlying cause could not be determined after reviewing the documentation in this investigation.

Event Description

The provider states both motor brakes appear to be stripped out and they are not stopping the chair.

• Brand Name: POWER CHAIR 20 WIDE BY 18 DEEP FOR PMI
• Type of Device: WHEELCHAIR, POWERED
• Manufacturer (Section D): INVACARE TAYLOR STREET; 1200 taylor street; elyria OH 44036
• Manufacturer (Section G): INVACARE TAYLOR STREET; 1200 taylor street; elyria OH 44036
• Manufacturer Contact: kevin guyton ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 5816192
• MDR Text Key: 50567400
• Report Number: 1525712-2016-02495
• Device Sequence Number: 1
• Product Code: ITI
• 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: 10/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: TDXSIV-HD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/04/2016
• 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