MAUDE Adverse Event Report: TI LITE (UNDER PERMOBIL) / TISPORT, LLC PERMOBIL TI LITE MANUAL WHEELCHAIR; WHEELCHAIR, MECHANICAL

Model Number ZR

Device Problems Loose or Intermittent Connection (1371); Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Date 02/04/2022

Event Type  Injury  

Event Description

Ti lite manual wheelchair malfunction issues for two wheelchairs for this veteran (zr sn (b)(4) and (b)(4)).Rear wheels not staying attached to chair properly with factory settings.Either axle sleeve and/or pin length issue and issue with receivers in camber tube loosening up.Undersigned clinician also informed that other co-workers have had similar issues for ti lite wheelchairs recently.I am encouraging them to submit similar reports.Issues were noted with factory settings of chair.Changes were not made to these parts during fitting before issue was noticed.Fda safety report id # (b)(4).

Event Description

Ti lite manual wheelchair malfunction issues for two wheelchairs for this veteran (zr sn (b)(4) and (b)(4)).Rear wheels not staying attached to chair properly with factory settings.Either axle sleeve and/or pin length issue and issue with receivers in camber tube loosening up.Undersigned clinician also informed that other co-workers have had similar issues for ti lite wheelchairs recently.I am encouraging them to submit similar reports.Issues were noted with factory settings of chair.Changes were not made to these parts during fitting before issue was noticed.Fda safety report id # (b)(4).

• Brand Name: PERMOBIL TI LITE MANUAL WHEELCHAIR
• Type of Device: WHEELCHAIR, MECHANICAL
• Manufacturer (Section D): TI LITE (UNDER PERMOBIL) / TISPORT, LLC; pasco WA 99301
• MDR Report Key: 13499853
• MDR Text Key: 285407573
• Report Number: MW5107314
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/04/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: ZR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Weight: 87 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White