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

Model Number	F5 CORPUS
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Unexpected Shutdown (4019)
Health Effect - Clinical Codes	Abrasion (1689); Bruise/Contusion (1754); Swelling/ Edema (4577)
Date of Event	08/02/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Received report claiming while the end-user was driving out of doors in their community, the power wheelchair allegedly came to an abrupt stop which forced the end-user to lose positioning and fall from the seating to the ground.This action reportedly resulted in minor injuries that did not necessitate the need for medical intervention.
Additional Manufacturer Narrative
End-user reported while driving in the community, the device allegedly stopped suddenly which forced the end-user to lose positioning and fall forward out of the seating to the street below.The end-user reported having sustained minor injuries to their left knee and right elbow, as well as a cut on their forehead.No reports of the end-user having sought medical intervention.Service provider reports having inspected the chair finding the drive motors and electric brakes to be within operational specifications.Further inspection shows signs of heavy corrosion at the terminal connection point of the main power module where the battery connection is made.It was also noted signs of heat buildup on the battery connector lead (plug) which connects to the power module.Permobil concludes the most probable cause for the reported sudden stoppage was loss of power due to corroded battery connection.It is reported the end-user is a very active outdoor user in/around their beach community, and with the information provided from the dealer technician, the most probable cause for this reported failure was due to lack of general maintenance with the corrosion being caused by environmental factors.Although there was no report of a serious injury, permobil has determined if a total loss of power during drive occurs with the lack of wearing the provided positioning belt, there is a potential risk for serious injury if failure were to recur.The dhr was reviewed, and the device was found to have met specifications prior to distribution.

• Brand Name: PERMOBIL F5 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: 17673544
• Report Number: 1221084-2023-00017
• Device Sequence Number: 6044936
• Product Code: ITI
• UDI-Device Identifier: 17330818229844
• UDI-Public: 17330818229844
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K143014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: F5 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: 08/07/2023
• Initial Report FDA Received Date: 09/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/23/2018
• 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
• Patient Sex: Prefer Not To Disclose