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

Model Number	M5 CORPUS
Medical Device Problem Codes	Mechanical Problem (1384); Unintended System Motion (1430); Unintended Movement (3026)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/15/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Permobil received correspondence from legal counsel representing the end-user where is was claimed the device elevated without the end-user physically engaging a seat command.This action reportedly caused the end-user to lose positioning and fall to the ground, where the ensuing fall reportedly resulted in an undefined serious injury to the end-user's ankle and knee.Review of the device history shown the device having shipped with -20° anterior tilt feature, and after hearing of the incident from the provider, a permobil representative removed the anterior tilt feature from the device programming.The device has been inspected by permobil to which they noticed the front lift actuator not holding secure after coming out of a tilt position.This action would allow the seating to tilt slightly forward when not holding.Interviews with the end-user did not make any claims this found actuator movement was what occurred to have contributed to the event, but permobil noted the irregularity and generated parts quote to address.Although an inspection indicated a component failure being active, permobil is unable to reach a determination at this time as to the actual cause for the event without speculation.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.
Event or Problem Description
Permobil received report from legal representative for the end-user claiming the end-user having sustained injuries related to an alleged malfunction with their m5 corpus pwc.Report claims the chair raised unexpectedly which caused the end-user to fall to the floor where they reportedly suffered undescribed serious injuries to their left ankle and knee.

• 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: 22860687
• Report Number: 1221084-2025-00012
• Device Sequence Number: 18449306
• Product Code: ITI
• UDI-Device Identifier: 17330818334562
• UDI-Public: (01)17330818334562(11)220131
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 08/21/2025

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: M5 CORPUS
• 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): Thirty-Day
• Initial Date Received by Manufacturer: 07/29/2025
• Initial Report FDA Received Date: 08/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/31/2022
• 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: Other
• Patient Sex: Unknown