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

Model Number	F3 CORPUS
Medical Device Problem Codes	Break (1069); Mechanical Problem (1384); Detachment of Device or Device Component (2907); Material Integrity Problem (2978)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/19/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation revealed that the root cause of this failure mode is contributed to "component failure".While the patient was in the wheelchair the right-side drive wheel detached from the device.The wheelchair was evaluated by the servicing vendor and the main hub bolt had sheared off, allowing the drive wheel to slide off the drive motor shaft.This is a known issue that has since been corrected.The failure was linked back to the supplier and related to an assembly error installing the wheel hub to the drive motor shaft.The risk for this failure to occur is low and the likely hood of injury to occur is also very low.Due to this known repeat failure mode, a capa has been opened for this failure by our parent company.As this device has exceeded its life expectancy, permobil has recommended to the service provider that both drive motor assemblies be replaced, or the device be removed from service and replaced with new.The dhr for this device has been reviewed and was found to have met specification prior to distribution.
Event or Problem Description
Reports while end-user was driving along a sidewalk, the left drive wheel became detached from the motor causing the device to drop to one side.This reportedly caused the end-user to lose the ability to maintain upright positioning, allowing them to slump forward in the seating requiring assistance to regain an upright position.Reports indicate the end-user sought medical intervention because of this event.

• 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: 16250195
• Report Number: 1221084-2023-00001
• Device Sequence Number: 6406337
• Product Code: ITI
• UDI-Device Identifier: 17330818676433
• UDI-Public: 17330818676433
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/26/2023

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2023
• Initial Report FDA Received Date: 01/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/21/2017
• 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