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

Model Number	F3 CORPUS
Medical Device Problem Codes	Mechanical Problem (1384); Mechanical Jam (2983)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Limb Fracture (4518)
Date of Event	02/01/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Received report claiming approximately 1 year prior, while the end-user was driving the wheelchair down the street, the wheelchair reportedly stopped which caused the end-user lose positioning and fall forward out of the seating to the ground where they sustained injuries requiring medical intervention to address.
Additional Manufacturer Narrative
Report provided from the end-user claimed while they were driving down the street, the wheelchair reportedly stopped which forced the end-user out of the seating and the device reportedly having fallen over atop of them resulting in a fracture to their left tibia requiring medical intervention.Reports indicate when the event occurred, the end-users dress had to be cut off as a portion of it had reportedly gotten entangled and was wrapped around the shaft of one of the drive motors.This event was reported to have occurred approximately 1 year prior and the end-user does not have recollection if they notified the service provider as to the extent of the injuries.It was reported the device remained fully operational, with the end-user utilizing the device daily for the last year with no reports of recurring issues and no history of service activities requiring the replacement of components.Inspection of the device found it to remain fully operational with no notable issues.Service provider hypothesized the probable cause of the reported event was due to the end-users dress becoming entangled in the wheelchairs drive motor.Due to the timespan of 1 year since event, and no reports or evidence of recurring behavior, permobil is concluding this event was caused by inadvertent use error.The dhr was reviewed and the device was found to have met specification prior 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: kevin bullock ; 300 duke drive; lebanon, TN 37090 ; 8007360925
• MDR Report Key: 13478737
• Report Number: 1221084-2022-00003
• Device Sequence Number: 14739352
• Product Code: ITI
• UDI-Device Identifier: 17330818676433
• UDI-Public: 17330818676433
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 02/08/2022

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/A
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2022
• Initial Report FDA Received Date: 02/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/04/2020
• 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: Female
• Patient Weight: 125 KG