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

Model Number	F3 CORPUS
Medical Device Problem Codes	Mechanical Problem (1384); Structural Problem (2506); Sharp Edges (4013)
Health Effect - Clinical Codes	Fall (1848); Unspecified Infection (1930); Laceration(s) (1946)
Date of Event	01/01/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reporter claims due to the extended time it is taking their provider to service the device, led to events resulting in injuries to the end-user.Reporter claims due to seating components being in an inoperable state, creates difficulty for the end-user while entering/exiting the seating system.This has allegedly led to the end-user having fallen numerous times during their transfers.Reporter also reports the end-user having cut their finger on the plastic portion of the arm rest body, and due to a pre-existing blood disorder, generated an infection which required the amputation of a finger.Investigation determined due to logistical issues; the components required to service the device were not shipped in a timely manner.It is permobil's contention that the reported component failure in and of itself was not the cause of the adverse event, but rather the end-user continuing to use the device in a diminished state leading to their inability to ingress/egress the seating safely.The dhr was reviewed, and the device was found to have met specification prior to distribution.
Event or Problem Description
Received report claiming due to the delays in service activities to repair various seating components, the end-user having difficulty entering and exiting the seating system which has led to the end-user having fallen on multiple occasions leading to injuries requiring medical attention to address.

• 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: 15743985
• Report Number: 1221084-2022-00022
• Device Sequence Number: 17917734
• Product Code: ITI
• UDI-Device Identifier: 17330818676433
• UDI-Public: 17330818676433
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 11/07/2022

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2022
• Initial Report FDA Received Date: 11/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/11/2017
• 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