• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TISPORT, LLC AERO T WHEELCHAIR

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

TISPORT, LLC AERO T WHEELCHAIR Back to Search Results
Model Number AERO Z
Device Problem Inadequacy of Device Shape and/or Size (1583)
Patient Problem Pressure Sores (2326)
Event Type  Injury  
Manufacturer Narrative

We reviewed the dhr for this chair, and it passed all applicable quality tests and configuration requirements, and met specifications as ordered by the dealer when it left the facility. The dealer and/or a therapist measure the user for a wheelchair. Tisport as the manufacturer builds the chair based on the measurements provided to us from the dealer and/or therapist. All documentation and specifications for the chair were appropriately disseminated to the health specialist working with the end user. Included in the labeling with the device, the health care advisor must properly and fully train the end user before use. This training includes an analysis to determine methods for safe use based on the end users function and ability.

 
Event Description

The end user alleges that due to the position his foot sits on his footplate, he formed a pressure sore on the heel of his foot.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameAERO T
Type of DeviceWHEELCHAIR
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 Key8298535
MDR Text Key134785915
Report Number3032618-2019-00003
Device Sequence Number1
Product Code IOR
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK990358
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation
Type of Report Initial
Report Date 02/01/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/01/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL NumberAERO Z
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/02/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/28/2015
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 02/01/2019 Patient Sequence Number: 1
-
-