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

Model Number AERO T

Device Problem Break (1069)

Patient Problem Head Injury (1879)

Event Date 07/30/2018

Event Type  malfunction  

Manufacturer Narrative

The injuries reported in this case were not considered to be serious, however there is a risk of serious injury in the case of a failure of anti-tips while engaged.The returned samples of the anti-tips were tested, along with samples from the then-current lot and of a different lot.The results of a combination of internal and external/third-party testing indicates that the material of the anti-tip tube used in the construction of this chair was softer and weaker than the design specified.

Event Description

The provider took the end user in their new wheelchair out to the parking lot of the hospital where the end user propelled themselves up a slight incline.Allegedly during this time, the chair rocked backwards and contacted the anti-tips three times, where on the third time the anti-tip tubes failed and the chair fell backwards.The provider claims that the end user hit his head and a ct was done, but that so far, he is okay.

• Brand Name: AERO T
• Type of Device: WHEELCHAIR ANTI-TIP
• 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: 7820446
• MDR Text Key: 118552394
• Report Number: 3032618-2018-00004
• Device Sequence Number: 1
• Product Code: IMR
• 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: company representative
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 08/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: AERO T
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/30/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/23/2018
• 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 Weight: 103