MAUDE Adverse Event Report: TISPORT, LLC ZRA; WHEELCHAIR

Model Number ZRA

Device Problems Fracture (1260); Use of Device Problem (1670)

Patient Problem Damage to Ligament(s) (1952)

Event Date 04/02/2019

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 measured 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.The device was not returned for evaluation.Based on the evidence provided, the fracture in the backrest bracket is likely the result of excessive forces introduced to the backrest assembly through impact or abuse.If more information is provided that changes the conclusions of the investigation, a follow up medwatch form 3500a will be filed.

Event Description

The end user alleges that while putting on his pants in the bathroom, the backrest hinges fractured, resulting in ligament damage in his arm.He is in a full arm cast, and will receive injections in his arm as treatment with the possibility of surgery for future treatment.

• Brand Name: ZRA
• 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: 8571403
• MDR Text Key: 143807983
• Report Number: 3032618-2019-00004
• 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: consumer
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 05/01/2019

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: ZRA
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/02/2019
• Initial Date FDA Received: 05/01/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/24/2015
• 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 Outcome(s): Required Intervention
• Patient Weight: 91