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

Model Number 3GAR-CG

Device Problems Device Stops Intermittently (1599); Noise, Audible (3273)

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 dealer states that the chair is intermittently cutting off again and the motors are making a popping noise in the right motor.

Manufacturer Narrative

Product was returned for evaluation.The return fields in oracle state: controller cable damaged.Per information gathering, the controller cable was dropped while preparing the product for the return.When the controller was dropped, it hit something metal, sparked, and looks like one of the prongs melted.Not part of the original complaint.Complaint was not confirmed, as the cable was damaged further while preparing to ship for investigation.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: controller cable damaged.Per information gathering, the controller cable was dropped while preparing the product for the return.When the controller was dropped, it hit something metal, sparked, and looks like one of the prongs melted.Not part of the original complaint.The dealer states that the chair is intermittently cutting off again and the motors are making a popping noise in the right motor.

• 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: 5063551
• MDR Text Key: 25807945
• Report Number: 1525712-2015-04495
• 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
• Report Date: 09/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 3GAR-CG
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/03/2015
• 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 Outcome(s): Other