MAUDE Adverse Event Report: PERMOBIL INC. PERMOBIL F3 CORPUS; POWERED WHEELCHAIR

Model Number	F3 CORPUS
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Burn(s) (1757); Partial thickness (Second Degree) Burn (2694); Full thickness (Third Degree) Burn (2696)
Date of Event	03/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Service provider received report from a skilled nursing facility stating while the end-user was utilizing the permobil power wheelchair in their garage, stated the device reportedly caught aflame which resulted in the end-user sustaining burns to the backs of their legs requiring medical intervention to address.
Additional Manufacturer Narrative
The report claims the end-user was in their garage and was heard by family member of yelling from the end-user, and noted the seating was reportedly aflame.The family member reportedly extinguished the flame and called for ems assistance.The end-user was reported to have received 2nd and 3rd degree burns on their legs that required skin grafts to resolve.Provider was made aware of the incident approximately 6 months after the event was reported to have occurred.Inspection shown the device to remain fully operational with no signs of damage to any of the cabling or electronics.It was noted that there were signs of charring and melting on the right calf pad and right front corner of the seat cushion.There was also noted damages to the outer casing of the right headlight which appears to be external from heated material dripping atop.Lighting remained operational indicating no electrical issues as being a possible cause.All inspection appears to indicate an outside source as causing the thermal activity.The end-user stated they have no recollection of the event or what could have been the catalyst for the thermal activity.As device remains fully operational with no signs of an electrical or mechanical malfunction having occurred, permobil is unable to reach a determination as to possible root cause.The dhr was reviewed, and the device was found to have met specification prior to distribution.

• Brand Name: PERMOBIL F3 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: 20433808
• Report Number: 1221084-2024-00019
• Device Sequence Number: 7608504
• Product Code: ITI
• UDI-Device Identifier: 17330818676433
• UDI-Public: 17330818676433
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K143180
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/11/2024

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: F3 CORPUS
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2024
• Initial Report FDA Received Date: 10/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/07/2022
• 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: Prefer Not To Disclose