MAUDE Adverse Event Report: PERMOBIL / TISPORT, LLC TILITE PILOT; WHEELCHAIR, MECHANICAL

Device Problems Device Slipped (1584); Material Integrity Problem (2978)

Patient Problem Insufficient Information (4580)

Event Date 10/20/2019

Event Type  Injury  

Event Description

Permobil produces a pediatric manual chair called the tilite pilot.The company is aware of a pervasive problem with the wheel locks where they will spontaneously stop working regularly.However, this is not disclosed to the consumer and no design changes has been made despite their awareness of the problem.My (b)(6) daughter's wheel locks fail almost weekly and have for almost two years.This is a major safety hazard because she and her support adults rely on her to be able to lock her wheels for safety.Please investigate this issue and get justice for all of us who have been lied to and risked injury.Fda safety report id # (b)(4).

• Brand Name: TILITE PILOT
• Type of Device: WHEELCHAIR, MECHANICAL
• Manufacturer (Section D): PERMOBIL / TISPORT, LLC
• MDR Report Key: 14282789
• MDR Text Key: 290798104
• Report Number: MW5109508
• Device Sequence Number: 1
• Product Code: IOR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 05/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 6 YR
• Patient Sex: Female
• Patient Weight: 19 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White