MAUDE Adverse Event Report: TISPORT, LLC ZRA; WHEELCHAIR

Model Number ZRA

Device Problems Detachment of Device or Device Component (2907); Installation-Related Problem (2965)

Patient Problem Joint Dislocation (2374)

Event Date 03/14/2018

Event Type  Injury  

Manufacturer Narrative

A review of the dhr indicates that the chair passed all applicable quality tests and configuration requirements, and met all specifications as ordered by the dealer when it left the facility.According to the dhr, the chair was ordered without the smartdrive axle clamp installed, meaning the dealer or other 3rd party would have installed the components.A field investigation revealed that the smartdrive axle clamp was not mounted to max mobility's specifications.The end user reported that her smartdrive "always felt wobbly" from the time she received it, but did not question the condition because she thought that it was normal.During the visit, the axle clamp was reinstalled correctly, and the end user and father were provided education and materials necessary to properly install and service the components in question.After the adjustments were made, the end user demonstrated appropriate use of the smartdrive and it's attachment to the axle clamp, and she commented that it felt more stable and less "wobbly." from the information gathered, it does not appear that the zra wheelchair was a relevant factor in the event or injury, as all the materials and services that contributed to the event were not tisport's.

Event Description

As described by the sales representative, the end user alleges that while using a smartdrive with her chair, the smartdrive disassembled from the chair causing her to veer into an embankment.She was treated at a hospital for a neck soft tissue injury and a dislocated knee.A follow up with the end user on (b)(6) 2018 revealed that she is predisposed to dislocated joints due to a connective tissue disorder, and that the treatment for the dislocated knee was routine for her as it "went right back in." we have not been provided any additional information about the injuries, other than these allegations, at this time.

• 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: 7449274
• MDR Text Key: 106137846
• Report Number: 3032618-2018-00002
• Device Sequence Number: 1
• Product Code: IOR
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K990358
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Remedial Action: Modification/Adjustment
• Type of Report: Initial
• Report Date: 04/20/2018

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: ZRA
• Device Catalogue Number: Z2FS2
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/21/2018
• Initial Date FDA Received: 04/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 17 YR