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

Model Number AERO Z

Device Problem Break (1069)

Patient Problem Fracture, Arm (2351)

Event Date 08/17/2018

Event Type  Injury  

Manufacturer Narrative

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).We have reached out to the end user for further information, but have not been provided any information about the status of the anti-tips, or any further details about the incident.If our investigation reveals any additional information that changes the nature of the conclusions reached in this report, a follow up medwatch form 3500a will be filed.

Event Description

Customer claims her wheelchair tipped backwards with her seated in it, resulting in bi lateral scaphoid fractures.The dhr indicates the extension tube was an x-short standard anti-tip.We have not been provided any additional information about the incident, other than these allegations, at this time.

• 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: 8162968
• MDR Text Key: 130311503
• Report Number: 3032618-2018-00013
• Device Sequence Number: 1
• Product Code: IOR
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K990358
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/13/2018

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 Z
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/14/2018
• Initial Date FDA Received: 12/13/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/24/2018
• 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
• Patient Outcome(s): Hospitalization