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

Model Number AERO T

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/31/2018

Event Type  malfunction  

Manufacturer Narrative

No injury was reported in this event.There is a risk of serious injury in the case of a failure of the 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 on the construction of this chair was softer and weaker than the design specified.

Event Description

The provider claims that they were performing an anti-tip check that they do with every client by having the user lean back on the anti-tips to make sure the front casters are not more than 4" off the ground; this test is performed on a level surface.While they did this check, the tech noticed the anti-tip extensions were beginning to bend.The tech claims that before this test, he adjusted the center of gravity as far back as he could, and tried to change the position where the anti-tip was mounted.

• 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: 7820451
• MDR Text Key: 118553271
• Report Number: 3032618-2018-00005
• 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: user facility
• Reporter Occupation: Non-Healthcare 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
• Date Manufacturer Received: 07/31/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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