MAUDE Adverse Event Report: TISPORT, LLC TILITE 2GX SERIES 2; WHEELCHAIR MECHANICAL

Model Number 2GX SERIES 2

Device Problem Fracture (1260)

Patient Problem Bruise/Contusion (1754)

Event Date 07/07/2016

Event Type  malfunction  

Manufacturer Narrative

Review of the dhr for this device was conducted, the chair was built according to specification.Although the chair or parts were not physically available for evaluation, photos were provided for investigational purposes.Evaluation of the photos revealed that a fracture in the component was a result of stress.In the history of tilite, this is the first of this component that has developed a fracture that has been reported.We are trying to get the part back in order to review the crack and efforts are being made to try and replicate this fracture.If additional information is received, a follow-up mdr will be filed.

Event Description

The axle clamp cracked, releasing the camber plug/axle sleeve and the client fell out of chair and landed on his amputated stump.

• Brand Name: TILITE 2GX SERIES 2
• Type of Device: WHEELCHAIR MECHANICAL
• Manufacturer (Section D): TISPORT, LLC; 2701 w court st; pasco WA 99301
• Manufacturer Contact: lindy anderlini ; 2701 w court st; pasco, WA 99301 ; 5095866117
• MDR Report Key: 5870493
• MDR Text Key: 51924512
• Report Number: 3032618-2016-00005
• Device Sequence Number: 1
• Product Code: IOR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072311
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 2GX SERIES 2
• Device Catalogue Number: G2FS1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/07/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/14/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other