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

Model Number AERO Z

Device Problem Break (1069)

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

Event Date 08/23/2018

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 x-short anti-tips shipped with this chair are part of a known population of x-short anti-tips that were potentially not made to the design specifications.Tisport, llc has initiated a voluntary market correction to mitigate the risk of injury to the end user, which is pending fda approval and assignment of correction/removal reporting number under 21 usc 360i(f).This voluntary market correction is tracked under cpa no.(b)(4).

Event Description

Customer claims the anti-tip extension tube bent.The dhr indicates the extension tube was an x-short standard anti-tip.

• Brand Name: AERO Z
• Type of Device: WHEELCHAIR
• 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: 7899898
• MDR Text Key: 121567915
• Report Number: 3032618-2018-00008
• 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: Other
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 09/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: AERO Z
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/23/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/04/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: PENDING
• Patient Sequence Number: 1