MAUDE Adverse Event Report: INVACARE TOP END DEMO 2 CROSSFIRE T7A; WHEELCHAIR, MECHANICAL

Model Number CT7A

Device Problem Detachment Of Device Component (1104)

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

Event Date 09/06/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Should additional information become available, a supplemental record will be filed.

Event Description

Mother of the enduser alleges the left castor fork has sheared off.

Manufacturer Narrative

Product was returned for evaluation.The return fields in oracle state: custom manual wheelchairs.Other, other/defective.Fork has broken off completely at wheel bushing hub.Product received expanded evaluation.The expanded evaluation report states: utilizing existing complaint information and actual observations of the returned product in its "as received" condition, the complaint was confirmed with respect to the alleged issue that the left caster fork had sheared off.Both sides of the fork cleanly sheared off from the wheel bushing hub portion of the fork assembly.Complaint was confirmed.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: custom manual wheelchairs.Other, other/defective.Fork has broken off completely at wheel bushing hub.Product received expanded evaluation.The expanded evaluation report states: utilizing existing complaint information and actual observations of the returned product in its "as received" condition, the complaint was confirmed with respect to the alleged issue that the left caster fork had sheared off.Both sides of the fork cleanly sheared off from the wheel bushing hub portion of the fork assembly.Mother of the enduser alleges the left castor fork has sheared off.

• Brand Name: DEMO 2 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: kevin guyton ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 5090569
• MDR Text Key: 26564896
• Report Number: 1056571-2015-00060
• 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: consumer
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Followup
• Report Date: 01/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2015
• 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: 01/20/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/20/2016
• 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