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

Model Number AERO T

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Tissue Damage (2104)

Event Type  Injury  

Manufacturer Narrative

The end user received treatment for the wound and reported that it was healing well.The dhr for this chair shows that it was configured correctly according to the order summary.The documentation and specifications for the chair were appropriately disseminated to the health specialist working with the end user.Upon receipt, the health specialist reviewed sideways stability with the end user through standard checks.In addition, the end user was provided a user manual that warns about ones center of gravity and how it relates to stability and balance, factors that can increase the risk of tip-overs, and procedures to follow to reduce the risk.For example, the user manual states: when you bend, reach or lean from your chair you will affect the center of balance of your chair.Therefore, bending, reaching or leaning may cause you to fall or tip over.In order to avoid falling or tipping over, you must determine your particular safety limitations given the configuration of your chair and your body weight and type.To do this, practice bending, reaching and leaning activities (and various combinations of such activities) under the supervision of your health care advisor.Do this before attempting active use of your chair.The user manual also states: when bending or leaning, always grasp one rear wheel with one hand.This will help to prevent a fall if the chair starts to tip over.Device evaluated by mfr: user misuse.

Event Description

The end user claims that when he was reaching for an object on the ground, the wheelchair flipped over sideways resulting in damage to the epidermis around his buttocks.

• Brand Name: AERO T
• 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: 6448600
• MDR Text Key: 71322477
• Report Number: 3032618-2017-00001
• 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: Patient
• Remedial Action: Modification/Adjustment
• Type of Report: Initial
• Report Date: 03/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2017
• 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
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/12/2015
• 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