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

Model Number	F3 CORPUS
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Fall (1848); Insufficient Information (4580)
Date of Event	01/15/2024
Type of Reportable Event	Death
Event or Problem Description
Received report claiming while the end-user was attempting to position the f3 corpus device on platform lift, the end-user inadvertently drove forward, off the platform, and down a flight of stairs.Report indicates the fall resulted with the end-user succumbing to their injuries.
Additional Manufacturer Narrative
Permobil received correspondence from the service provider, via the end-users family, describing an incident having occurred were while the end-user was in process of positioning their f3 powerchair on to a platform lift designed to transport a wheelchair up and down a flight of stairs.Witnesses indicate during the process of attempting to center the wheelchair upon the platform, the end-user inadvertently engaged a forward drive command on the joystick which propelled the device off the end of the platform resulting in the wheelchair, with the end-user, falling from the elevated height and down the fight of stairs.The end-users family was not forthcoming as to the extent of injuries, only reporting the end-user having received signifant injuries that eventually resulted in their death.No claims or allegations were made from witnesses or family members, to the service provider or to permobil, of any product malfunction having occurred to have contributed to this unfortunate event.All reports from witnesses indicate this event was caused by the inadvertent user error in intentional engagement of a drive command from an elevated surface.The dhr was reviewed, and the device was found to have met specification pror 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: 18707495
• Report Number: 1221084-2024-00001
• Device Sequence Number: 17943290
• Product Code: ITI
• UDI-Device Identifier: 17330818676433
• UDI-Public: 17330818676433
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/14/2024

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/12/2018
• 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: Prefer Not To Disclose