MAUDE Adverse Event Report: INVACARE TOP END DEMO 1 CROSSFIRE T7A; WHEELCHAIR, MECHANICAL

Model Number CT7A

Device Problem Material Separation (1562)

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

Event Type  malfunction  

Event Description

Dealer states the wheel lock fell apart while the end user was trying to lock the unit.

• Brand Name: DEMO 1 CROSSFIRE T7A
• Type of Device: WHEELCHAIR, MECHANICAL
• Manufacturer (Section D): INVACARE TOP END; pinellas park FL
• Manufacturer (Section G): INVACARE TOP END; pinellas park FL
• Manufacturer Contact: karen loughren ; one invacare way; elyria, OH 44036 ; 8003336900
• MDR Report Key: 4334012
• MDR Text Key: 5142991
• Report Number: 1056571-2014-00059
• 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: 10/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2014
• 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?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/29/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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