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

Model Number AERO T

Device Problem Unintended System Motion (1430)

Patient Problem No Information (3190)

Event Date 05/08/2020

Event Type  Injury  

Manufacturer Narrative

The dhr for this chair was reviewed and the chair passed all applicable quality tests and configuration requirements.It met all specifications when it left the facility.The client got a new aero t wheelchair (b)(6) 2020.On (b)(6) 2020 we did a warranty replacement of the backrest hinges and the release bar.This was because the locking backrest was not locking and kept popping forward.The dealer was not able to fix the problem.Limited information was provided by the customer regarding the exact nature of the alleged incident.The customer claims that while performing pressure relief, the chair back "popped" forward, causing them to fall forward out of the chair.According to the information provided, this incident resulted in a trip to the emergency room.However, no further information regarding the injuries sustained was provided.We have requested that the chair be returned but have not yet received it.A follow up medwatch form 3500a will be submitted if any additional information is provided.

Event Description

The customer alleges that while performing pressure relief, the chair back did not stay locked in the upright position and caused the user to fall forward, sustaining an unknown injury.

• Brand Name: AERO T
• Type of Device: WHEELCHAIR
• Manufacturer (Section D): TISPORT, LLC; 2701 w court st; pasco, wa,
• Manufacturer Contact: fred ortmann ; 2701 w court st; pasco, wa ; 5866117
• MDR Report Key: 10120224
• MDR Text Key: 195576414
• Report Number: 3032618-2020-00004
• 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: distributor
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 06/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: AERO T
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/08/2020
• Initial Date FDA Received: 06/04/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/07/2020
• 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): Other