MAUDE Adverse Event Report: INVACARE TOP END TRANSPORT 20 IN X 16 IN 9153637574; WHEELCHAIR, MECHANICAL

Model Number CT7A

Device Problem Material Integrity Problem (2978)

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 frame was just installed on this chair.The provider states the chair was with the consumer for a week and he received a call stating the left front fork came out of the housing.

Manufacturer Narrative

Additional/updated information was added to reflect the base frame being returned to the manufacturer for evaluation.The result of the evaluation was that the threaded stud came loose from the right side head tube, which confirmed the original complaint issue.However, the underlying cause could not be determined after reviewing the documentation in this investigation.(b)(4).

Event Description

The provider states frame was just installed on this chair.The provider states the chair was with the consumer for a week and he received a call stating the left front fork came out of the housing.

• Brand Name: TRANSPORT 20 IN X 16 IN 9153637574
• Type of Device: WHEELCHAIR, MECHANICAL
• Manufacturer (Section D): INVACARE TOP END; 1200 taylor street; pinellas park FL 44036
• Manufacturer (Section G): INVACARE TOP END; 1200 taylor street; pinellas park FL 44036
• Manufacturer Contact: kevin guyton ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 5747603
• MDR Text Key: 48140458
• Report Number: 1525712-2016-02192
• 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: 07/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: CT7A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/18/2016
• 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