MAUDE Adverse Event Report: PERMOBIL INC. PERMOBIL M1; POWERED WHEELCHAIR

Model Number	M1
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	01/04/2026
Type of Reportable Event	Death
Additional Manufacturer Narrative
Correspondence from a law firm representing the end-user's family alleges that the end-user was seated in the m1 power wheelchair while inside their home when the device caught on fire.The letter alleges without foundation or evidence that the fire resulted from a malfunction or failure of the wheelchair's battery and/or related electrical components.The deceased end-user was alone at the time the fire originated and, therefore, there are no witnesses to the cause.The local fire department's initial investigation could not determine a cause of the fire.The fd report indicates two potential theories of ignition: (1) the end-user's pipe smoking and (2) the wheelchair's battery and/or electronics.Permobil is investigating the origin of the fire but cannot render an opinion as to root cause at this time.Permobil will continue its investigation into the root cause of the fire.If any new information regarding the cause is obtained, a follow-up report will be submitted.
Event or Problem Description
Permobil received correspondence from a law firm representing the family of a deceased end-user wherein it is alleged that the end-user's m1 power wheelchair caught on fire which resulted in catastrophic injuries and death to the end-user.The letter alleges without foundation or evidence that fire initiated within the power wheelchair.

• Brand Name: PERMOBIL M1
• 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: 24381920
• Report Number: 1221084-2026-00001
• Device Sequence Number: 10208230
• Product Code: ITI
• UDI-Device Identifier: 17330818252316
• UDI-Public: (01)17330818252316(11)230706
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K123290
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/18/2026

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: M1
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/27/2026
• Initial Report FDA Received Date: 02/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/06/2023
• 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: Death
• Patient Sex: Unknown