MAUDE Adverse Event Report: PERMOBIL INC. PERMOBIL M3 CORPUS; POWERED WHEELCHAIR

Model Number	M3 CORPUS
Medical Device Problem Codes	Mechanical Problem (1384); Unintended System Motion (1430); Unintended Movement (3026)
Health Effect - Clinical Codes	Fall (1848); Brain Injury (2219)
Date of Event	05/07/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Permobil conducted an inspection of the device and received testimony from the end-user of sequence of events leading to the reported incident.Reports indicate the end-user having left the device powered on during a transfer, and they position the joystick up and behind the backrest during transfers.Inspection of this position shows the joystick inductive as being close to the headrest and the slightest movement of the joystick could allow the inductive to be deflected to engage a drive command.Inspection of the device was found to remain fully operational with no signs of a malfunction having occurred.The end-user was provided the information of the findings and was re-instructed to ensure the device is powered off during transfers.The end-user voiced their understanding and accepted the findings.The dhr was reviewed, and the device was found to have met specification prior to distribution.
Event or Problem Description
Received report claiming while the end-user was in process of performing a transfer into the power wheelchair, the device reportedly initiated a drive command which pinned the end-user against the bed eventually causing the user to fall to the ground where they sustained injuries requiring medical intervention to address.

• Brand Name: PERMOBIL M3 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: 22178419
• Report Number: 1221084-2025-00007
• Device Sequence Number: 15663930
• Product Code: ITI
• UDI-Device Identifier: 17330818345674
• UDI-Public: (01)17330818345674(11)240319
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/10/2025

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: M3 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: 05/20/2025
• Initial Report FDA Received Date: 06/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/19/2024
• 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: Hospitalization
• Patient Sex: Unknown