MAUDE Adverse Event Report: PERMOBIL INC. PERMOBIL M5 CORPUS; POWERED WHEELCHAIR

Model Number	M5 CORPUS
Medical Device Problem Codes	Fire (1245); Temperature Problem (3022)
Health Effect - Clinical Codes	Burn(s) (1757); Full thickness (Third Degree) Burn (2696)
Date of Event	12/02/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Report claims as the end-user was sleeping in their device while being under charge, the device reportedly caught aflame resulting in injuries requiring medical intervention to address.
Additional Manufacturer Narrative
Report claims the end-user was sleeping in the m5 corpus power wheelchair while inside their transport vehicle.Reports while the device was in the motor vehicle, an extension cord was run from the residence, to the van, to charge the batteries.Report claims at some point, the power wheelchair caught aflame causing burns to the end-users right leg and buttock requiring skin graphs to address.The end-user reported they had nothing else plugged in at the time other than the charger, and they assume the batteries in the chair ignited.At this time the device has not been made available for inspection to confirm a product malfunction had occurred, thus permobil is unable to reach a determination as to cause.If any new information is received, a follow-up report will be submitted.
Additional Manufacturer Narrative
Further investigation and interviews indicate there weren't any extension cords run to the vehicle, and the device was not being charged as originally reported.Inspection of the device and scene shown all damages to the device appearing to have originated from an external source.Damages sustained to the device were all located to the outside left of the device, with signs of the initial ignition point as being in/around the motor vehicle drivers seating.No signs of any electrical wiring, batteries, or component failure having occurred on the power wheelchair, with all damages to the power wheelchair being external.

• Brand Name: PERMOBIL M5 CORPUS
• Common Device Name: POWERED WHEELCHAIR
• Manufacturer (Section D): PERMOBIL INC.; 300 duke drive; lebanon TN 37090
• Manufacturer (Section G): PERMOBIL INC.; 300 duke drive; lebanon TN 37090
• Manufacturer Contact: ivan fernandez ; 300 duke drive; lebanon, TN 37090 ; 8007360925
• MDR Report Key: 23925919
• Report Number: 1221084-2025-00020
• Device Sequence Number: 9013828
• Product Code: ITI
• UDI-Device Identifier: 17330818334562
• UDI-Public: (01)17330818334562(11)211025
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K123290
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/15/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: M5 CORPUS
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/04/2025
• Supplement Date Received by Manufacturer: 01/14/2026
• Initial Report FDA Received Date: 12/30/2025
• Supplement Report FDA Received Date: 01/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/25/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown