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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TISPORT, LLC AERO T WHEELCHAIR

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TISPORT, LLC AERO T WHEELCHAIR Back to Search Results
Model Number AERO T
Device Problem Unintended System Motion (1430)
Patient Problem No Information (3190)
Event Date 05/08/2020
Event Type  Injury  
Manufacturer Narrative

The dhr for this chair was reviewed and the chair passed all applicable quality tests and configuration requirements. It met all specifications when it left the facility. The client got a new aero t wheelchair (b)(6) 2020. On (b)(6) 2020 we did a warranty replacement of the backrest hinges and the release bar. This was because the locking backrest was not locking and kept popping forward. The dealer was not able to fix the problem. Limited information was provided by the customer regarding the exact nature of the alleged incident. The customer claims that while performing pressure relief, the chair back "popped" forward, causing them to fall forward out of the chair. According to the information provided, this incident resulted in a trip to the emergency room. However, no further information regarding the injuries sustained was provided. We have requested that the chair be returned but have not yet received it. A follow up medwatch form 3500a will be submitted if any additional information is provided.

 
Event Description

The customer alleges that while performing pressure relief, the chair back did not stay locked in the upright position and caused the user to fall forward, sustaining an unknown injury.

 
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Brand NameAERO T
Type of DeviceWHEELCHAIR
Manufacturer (Section D)
TISPORT, LLC
2701 w court st
pasco, wa,
Manufacturer Contact
fred ortmann
2701 w court st
pasco, wa 
5866117
MDR Report Key10120224
MDR Text Key195576414
Report Number3032618-2020-00004
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 DISTRIBUTOR
Reporter Occupation
Remedial Action Replace
Type of Report Initial
Report Date 06/04/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/04/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL NumberAERO T
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/08/2020
Was Device Evaluated By Manufacturer? No
Date Device Manufactured01/07/2020
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: 06/04/2020 Patient Sequence Number: 1
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