MAUDE Adverse Event Report: PERMOBIL INC. PERMOBIL F5; POWERED WHEELCHAIR

Model Number	F5
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Death (1802)
Date of Event	01/14/2020
Type of Reportable Event	Death
Additional Manufacturer Narrative
Reports provided by the end-users family member claim as the end-user was utilizing the device while in their garage, they were attempting to light a wood burning stove using a propane torch normally used for weed control.Reports indicate the end-user had lost their grip of the torch handle, dropping it in their lap which subsequently ignited the end-users clothing.Reports indicate the end-user was transported to the area burn center where they eventually succumbed and died after suffering 3rd degree burns to over 85% of their body.All accounts received claim this unfortunate incident was strictly use error and the device did not deviate or malfunction in any way to have contributed to this event.As the result of the external thermal activity, the device sustained considerable damages rendering it inoperable.The dhr was reviewed and device met specification prior to distribution.
Event or Problem Description
Received report claiming as the end-user was attempting to light a wood burning stove with a torch, they inadvertently dropped the torch in their lap subsequently igniting their clothing.End-user was reported to have sustained grave injuries as a result.

• Brand Name: PERMOBIL F5
• Common Device Name: POWERED WHEELCHAIR
• Manufacturer (Section D): PERMOBIL INC.; 300 duke drive; lebanon TN 37090
• MDR Report Key: 9673483
• Report Number: 1221084-2020-00004
• Device Sequence Number: 11484202
• Product Code: ITI
• UDI-Device Identifier: 17330818229844
• UDI-Public: 17330818229844
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K143180
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: F5
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/14/2020
• Initial Report FDA Received Date: 02/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Weight: 110