MAUDE Adverse Event Report: TISPORT, LLC ZRA SERIES 2; WHEELCHAIR MECHANICAL

Model Number ZRA SERIES 2

Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

Patient Problem Bone Fracture(s) (1870)

Event Date 02/17/2016

Event Type  Injury  

Manufacturer Narrative

The dealer and/or a therapist measure the user for a wheelchair.Tilite as the manufacturer builds a chair based on the measurements provided to us from the dealer and/or therapist.Tilite does not choose the style or measurement of the front frame taper.This information comes from the user.Training on how to use the chair also comes from the dealer and/or therapist as well as help from the user manual, provided with each tilite chair.The result of the incident was an accident based on the user's actions.The dhr for this device was reviewed and the chair was built according to specification.User misuse.

Event Description

The customer was transferring out of her tilite chair, got her foot caught in the front of the frame.She proceeded to twist and break her leg.She complained the front taper of the chair is too wide and hindered with her transfer.

• Brand Name: ZRA SERIES 2
• Type of Device: WHEELCHAIR MECHANICAL
• Manufacturer (Section D): TISPORT, LLC; 2701 w court st; pasco WA 99301
• Manufacturer Contact: lindy anderlini ; 2701 w court st; pasco, WA 99301 ; 5095866117
• MDR Report Key: 5788365
• MDR Text Key: 49364985
• Report Number: 3032618-2016-00003
• 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: Patient
• Type of Report: Initial
• Report Date: 06/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: ZRA SERIES 2
• Device Catalogue Number: Z2FS2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/17/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/02/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention