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

Model Number	F3 CORPUS
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Power Problem (3010); Complete Loss of Power (4015)
Health Effect - Clinical Code	Heat illness (4907)
Date of Event	07/29/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Received report that while the end-user was operating their device out-of-doors, the device reportedly shut down leaving them stranded in the heat.Report indicated the end-user self-diagnosed with claims of having suffered heat stroke as a result.No reports were provided of medical intervention being sought.
Additional Manufacturer Narrative
Report claims as the end-user was out-of-doors in a metropolitan setting, the m5 power wheelchair suddenly lost power and they were unable to restart the device.Reports indicate it was a hot day, and the end-user was stuck out in the heat for approximately 2 hours.The end-user professed having suffered heat stroke but did not indicate seeking medical intervention.The end-user stated regardless of the amount they used the device, the battery indicator on the joystick display remained at 100% and they did not know the accurate level of charge.Inspection of the device did confirm the battery level indicator staying at 100%, but in review of the devices electronic history, the battery levels never dropped below 50% capacity.Permobil is continuing to investigate the possible cause for the reported loss of power, and if any new information is received, a follow-up report will be submitted.The dhr was reviewed, and the device was found to have met specification prior to distribution.

• 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: 22820284
• Report Number: 1221084-2025-00011
• Device Sequence Number: 5738992
• Product Code: ITI
• UDI-Device Identifier: 17330818334562
• UDI-Public: (01)17330818334562(11)240731
• 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): Y
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/15/2025

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: 07/29/2025
• Initial Report FDA Received Date: 08/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/31/2024
• 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: Other
• Patient Sex: Unknown