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

Model Number	F3 CORPUS
Medical Device Problem Codes	Mechanical Problem (1384); Unintended System Motion (1430); Unintended Movement (3026)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	08/31/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Permobil counsel received correspondence from legal counsel retained by the end-user where it was alleged of a malfunction having occurred with the permobil f3 corpus where it claims while the end-user was in their driveway, the electronics reportedly took control and started to drive the chair towards a busy street.The end-user reportedly grabbed the joystick to maintain control and in so doing, the device reportedly drove off a curb and landed atop the end-user to where they sustained a fracture to their pinky finger reportedly requiring a surgical procedure to correct.The local service provider attempted to inspect the device, but activities were declined by the end-user reporting their legal counsel advised against any service until further notice.As the device is unavailable for inspection, permobil is unable to confirm a product malfunction has occurred and is unable to determine a probable root cause without speculation.When permobil receives any new information, a follow-up report will be submitted.
Event or Problem Description
Received report claiming while the end-user was operating the f3 corpus in their driveway, suddenly the electronics took control, and as the end-user was attempting to keep from going into the busy street, the device drove off a curb and landed atop of the end-user resulting in injuries requiring medical intervention to address.

• 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: 18096801
• Report Number: 1221084-2023-00023
• Device Sequence Number: 20488668
• Product Code: ITI
• UDI-Device Identifier: 17330818676433
• UDI-Public: 17330818676433
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/08/2023

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): Initial
• Initial Date Received by Manufacturer: 10/16/2023
• Initial Report FDA Received Date: 11/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2023
• 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