MAUDE Adverse Event Report: TISPORT, LLC TILITE AERO R; WHEELCHAIR MECHANICAL

Model Number AERO R FIXED FRONT

Device Problems Break (1069); Device Maintenance Issue (1379); Misassembly by Users (3133)

Patient Problem Bone Fracture(s) (1870)

Event Date 06/04/2016

Event Type  malfunction  

Manufacturer Narrative

Review of the dhr for this device was conducted, the chair was built according to specification.Although the chair was physically not available for evaluation, photos were provided for investigational purposes.Evaluation of the photos revealed that a substantial accumulation of debris was found in the stem threads which could have contributed to the incident.Additionally, the secondary retention mechanism was observed to have failed and the split pin into the caster stem housing and stem is missing.Further investigation revealed that the device was manufactured in november 2010.This is older than the life span for an average wheelchair according to industry standards.Due to the amount of debris and general overall condition of the chair, the root cause of the incident was found to be improper maintenance.The tilite user's manuals state "inspect wheel/fork assembly/stem bolt to ensure that stem bolt is secure (wheel/fork assembly should not have excessive play relative to the stem bolt but should rotate freely); if necessary, tighten stem bolt".Pictures were provided by dealer.

Event Description

As reported by the user's father, the user was going from her house into the garage (platform at top of ramp).When she rolled over the threshold and onto the ramp, the front right caster fell off causing her to topple off the ramp and onto the ground near her car.She managed to reach her cell phone to call the squad for help.She was transported to a local hospital and then transported to (b)(6) medical center.She broke both of her femurs, and had surgery this week.She is still in the hospital and is expected to transfer to (b)(6) for inpatient rehabilitation this week.Pictures were supplied of the chair.The pictures show the standard solid fooplate has been cut in half and the frame has been modified for an ez lock system.According to the father, the user drives her vehicle from her chair which is why the footplate has been modified (cut) to allow her to roll into her lock down system.Information shared by (b)(4) when asked about service, (b)(6) brought her chair in last month for service.According to work order, "clean front casters".Technicians replaced and sealed the bearings, but claims to have not done anything to the stem bolt, per report.

• Brand Name: TILITE AERO R
• 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: 5788368
• MDR Text Key: 49383048
• Report Number: 3032618-2016-00004
• Device Sequence Number: 1
• Product Code: IOR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072311
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 07/01/2016

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: AERO R FIXED FRONT
• Device Catalogue Number: ARFS2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/08/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/05/2010
• 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
• Patient Age: 45 YR
• Patient Weight: 54