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

Model Number AERO X

Device Problems Misassembled (1398); Maintenance Does Not Comply To Manufacturers Recommendations (2974)

Patient Problems Fall (1848); Head Injury (1879); Injury (2348)

Event Date 11/30/2016

Event Type  Injury  

Manufacturer Narrative

We reviewed the dhr for this chair, and it passed all applicable quality tests and configuration requirements, and met all specifications as ordered by the dealer when it left the facility.The device was not returned for evaluation.If more information is provided, a follow up medwatch form 3500a will be filed.

Event Description

The end user alleges that shortly after a technician serviced her chair, the chair became non-maneuverable, then the serviced component disassembled, causing her to fall sideways and backwards.The fall injured her back, neck and head; the injury to the end user's head required stitches.We have not been provided any additional information about the fall, other than these allegations, at this time.

• Brand Name: AERO X
• Type of Device: WHEELCHAIR
• Manufacturer (Section D): TISPORT, LLC; 2701 w court st; pasco WA 99301
• Manufacturer Contact: edwin anderson ; 2701 w court st; pasco, WA 99301 ; 5095866117
• MDR Report Key: 6712804
• MDR Text Key: 80010952
• Report Number: 3032618-2017-00003
• 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: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: AERO X
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/20/2016
• 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): Hospitalization