MAUDE Adverse Event Report: TISPORT, LLC AERO T; WHEELCHAIR

Model Number AERO Z

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem Pressure Sores (2326)

Event Type  Injury  

Manufacturer Narrative

We reviewed the dhr for this chair, and it passed all applicable quality tests and configuration requirements, and met specifications as ordered by the dealer when it left the facility.The dealer and/or a therapist measure the user for a wheelchair.Tisport as the manufacturer builds the chair based on the measurements provided to us from the dealer and/or therapist.All documentation and specifications for the chair were appropriately disseminated to the health specialist working with the end user.Included in the labeling with the device, the health care advisor must properly and fully train the end user before use.This training includes an analysis to determine methods for safe use based on the end users function and ability.

Event Description

The end user alleges that due to the position his foot sits on his footplate, he formed a pressure sore on the heel of his foot.

• Brand Name: AERO T
• Type of Device: WHEELCHAIR
• Manufacturer (Section D): TISPORT, LLC; 2701 w court st; pasco WA 99301
• Manufacturer Contact: brian english ; 2701 w court st; pasco, WA 99301 ; 5095866117
• MDR Report Key: 8298535
• MDR Text Key: 134785915
• Report Number: 3032618-2019-00003
• Device Sequence Number: 1
• Product Code: IOR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K990358
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: AERO Z
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/02/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/28/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention