MAUDE Adverse Event Report: TISPORT, LLC ZRA; WHEELCHAIR

Model Number ZRA

Device Problem Misassembly During Maintenance/Repair (4054)

Patient Problems Fall (1848); Bone Fracture(s) (1870)

Event Type  Injury  

Manufacturer Narrative

We reviewed the dhr for this chair, and it passed all applicable quality tests and configuration requirements, and met all specifications as ordered when it left the facility.In discussing the series of events with the end user, it was revealed that the bolt that disassembled had been recently removed and reassembled due to maintenance performed on the caster bearings by an independent technician.No company name was provided for this technician, just his name and that he was someone who had accounts that allowed him to get parts.

Event Description

The end user claims that following maintenance to her casters from an independent 3rd-party, she was using her wheelchair when a bolt disassembled from the front caster, causing the wheel to fall off without her noticing.She claims the abrupt stop resulting from her caster fork contacting the ground caused her to fall from the chair and break her femur.The injury required surgery and implants.The latest communication with the customer indicates she is recovering and in good health.

• 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: 8137921
• MDR Text Key: 129574377
• Report Number: 3032618-2018-00010
• 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
• Type of Report: Initial
• Report Date: 12/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2018
• 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
• Date Manufacturer Received: 10/26/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/15/2015
• 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): Hospitalization