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	Laceration(s) (1946)
Date of Event	08/14/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reports indicate the end-user sustained tears to the skin on their forearm, but injuries were addressed at home by the end-users wife who is an rn.Dealer reports having inspected the device and was unable to replicate any issue of the device driving erratic as reported, finding the device to remain fully operational with no signs of malfunction having occurred.It remains unclear as to possible cause for the reported event leaving permobil unable to reach a determination as to root cause without speculation.The dhr was reviewed, and device was found to have met specification prior to distribution.
Event or Problem Description
Reports while exiting transport vehicle via incorporated ramp, when transitioning from vehicle to ramp, the device reportedly spun to the left very quickly which forced the end-users arm against the vehicle door frame, resulting in lacerations to their forearm.

• 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: 20202557
• Report Number: 1221084-2024-00017
• Device Sequence Number: 7676216
• Product Code: ITI
• UDI-Device Identifier: 17330818676433
• UDI-Public: 17330818676433
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/12/2024

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?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2024
• Initial Report FDA Received Date: 09/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/09/2021
• 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: Required Intervention
• Patient Sex: Prefer Not To Disclose