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

Model Number	F5 CORPUS VS
Medical Device Problem Codes	Mechanical Problem (1384); Unintended Movement (3026); Device Fell (4014)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Limb Fracture (4518)
Date of Event	08/24/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Permobil representative received call from end-user reporting as when they were exiting their transport vehicle via an incorporated ramp, one of the drive motors was reported to have "locked up" yet the remaining motor continued to drive.This reportedly forced the chair to turn quickly to where it rolled off the side of the ramp with the end-user remaining in the seating.Report provided claims the ensuing fall caused the end-user to sustain a fx to their left tibia.It was reported the end-user having had a set of older motor/gearbox assemblies on hand, and that either they or a friend reportedly replaced the suspect motor/gearbox so the end-user to continue use of the device until the new components were ordered and installed.The permobil representative informed the end-user that using an old part was not recommended, but the end-user stated they could not wait for dealer service.Permobil was informed that the suspect motor/gearbox had been discarded by the end-user prior to permobil becoming aware of the event.As suspect components were reported to have been discarded, permobil is unable to evaluate to confirm a product malfunction occurred, therefore are unable to determine a probable root cause without speculation.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 exiting their transport vehicle via the incorporated ramp, one of the drive motors was alleged to have "locked-up" which reportedly caused the device to turn and drive off the side of the ramp.The ensuing fall resulted in an injury to the end-user 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: 15490701
• Report Number: 1221084-2022-00017
• Device Sequence Number: 16608495
• Product Code: IPL
• UDI-Device Identifier: 17330818229844
• UDI-Public: 17330818229844
• 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): 09/26/2022

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2022
• Initial Report FDA Received Date: 09/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/27/2017
• 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