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

Model Number	F3 CORPUS
Medical Device Problem Codes	Mechanical Problem (1384); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Limb Fracture (4518)
Date of Event	11/11/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Initial reports received allege the left footplate having detached from the legrest assembly causing the end-user's foot to fall underneath the drive wheel of the wheelchair.This event is reported to have cause the user injury.Interview with the end-user's wife indicate that some swelling and bruising was identified around the left ankle 2-days after the event.Permobil has requested to inspect the wheelchair and is making arrangements to verify the circumstances surround the reported failure.Therefore, investigation into root cause is pending at this time.After an evaluation of the device is complete and a determination into root cause of the failure is further understood, a follow-up report will be submitted.The dhr for this device has been reviewed and the wheelchair met specification prior to distribution.
Event or Problem Description
Received report from end-users wife claiming the left footplate slid out of the receiver bracket.This allowed the end-users foot to drop down which reportedly got caught under the drive wheel causing a fracture to the left tibia.
Additional Manufacturer Narrative
Permobil representative inspected the device and found the footplate reported to have detached had been re-installed by the end-user.The description of the event indicated the hardware designed to secure the leg tube and footplate to the leg rest assembly had loosened which allowed the footplate assembly to fall out of the receiver.Inspection shown all hardware remained intact and no physical or mechanical defects were noted.Through interviews with the end-user, it was reported the end-user routinely applies pressure to the footplates to re-position themselves.The end-user reported not having any routine service performed to the leg rest/footplate assembly since initial receipt 1.5 years prior.Permobil representative concluded that without general maintenance, overtime, the hardware that secures the leg tube to the leg rest assembly became loose allowing the footplate to detach.The end-user was verbally instructed that routine maintenance should be performed as outlined in the user manual.

• 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: kevin bullock ; 300 duke drive; lebanon, TN 37090 ; 8007360925
• MDR Report Key: 13015087
• Report Number: 1221084-2021-00042
• Device Sequence Number: 5188236
• Product Code: ITI
• UDI-Device Identifier: 17330818676433
• UDI-Public: 17330818676433
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2022

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/
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/16/2021
• Supplement Date Received by Manufacturer: 01/28/2022
• Initial Report FDA Received Date: 12/15/2021
• Supplement Report FDA Received Date: 01/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/14/2020
• 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: Male
• Patient Weight: 107 KG