MAUDE Adverse Event Report: PERMOBIL INC. PERMOBIL F5 CORPUS VS; POWERED WHEELCHAIR

Model Number	F5 CORPUS VS
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Limb Fracture (4518)
Date of Event	09/15/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Report claims as the end-user was maneuvering the device through their living room via sip-n-puff drive controls, claims having run the chair into a piece of exercise equipment.End-user reported they were able to maneuver out and away, not noticing anything out of normal.Later that evening when being removed from their device to go to bed, reported seeing a notable swelling in their right leg.They were later diagnosed as having sustained a fracture to their femur, just above the knee.The end-user described nothing out of the norm having occurred with the device but did mention the drive settings for the sip-and-puff controls were more sensitive from what they were accustom.End-user mentioned having difficulty, in certain scenarios, of being able to control the turns and rates due to the sensitive nature.End-user made no claims of the device having malfunctioned to have caused the impact but did inquire if the settings could be adjusted to provided them with better control.Adjustments were made to parameter settings to decrease turn speed and acceleration, tested by the end-user who claims the device is much more manageable for their needs.All accounts indicate no product malfunction occurred to have contributed to this event.End-user was instructed to reach out to their provider if they feel any further programming adjustments are required.The dhr was reviewed, and the device was found to have met specification prior to distribution.
Event or Problem Description
Received report claiming as the end-user was maneuvering their device through their living room via sip-and-puff drive controls, they inadvertently drove the device into an immovable object resulting in an injury requiring medical intervention to address.

• Brand Name: PERMOBIL F5 CORPUS VS
• 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: 15702095
• Report Number: 1221084-2022-00021
• Device Sequence Number: 6227355
• Product Code: IPL
• UDI-Device Identifier: 17330818001006
• UDI-Public: 17330818001006
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K191874
• 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): 10/31/2022

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: F5 CORPUS VS
• 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: 10/06/2022
• Initial Report FDA Received Date: 10/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2022
• 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