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

Model Number F3 CORPUS

Device Problems Mechanical Problem (1384); Unintended Collision (1429); Unintended Movement (3026)

Patient Problem Bone Fracture(s) (1870)

Event Date 09/16/2022

Event Type  Injury  

Event Description

Received report as the end-user was turning the device inside an elevator, the device reportedly turned too far causing end-user to strike foot against the wall resulting in an injury requiring medical attention.

Manufacturer Narrative

Report received indicates while the end-user was entering an elevator and performing a turn face the chair to the doorway, the end-user claims when attempting to stop the turn by releasing the joystick, the device continued to turn allowing their foot to strike the doorway opening.This contact reportedly caused the end-user to sustain a broken metatarsal.Inspection of the device was conducted by the service provider who reported not finding any operational issues.Device was reported to be fully responsive, and they were unable to replicate the continued drive/failure to stop as described by the end-user.As device was found to be fully operational with no signs of mechanical or electrical malfunctions having occurred, and no reports of recurring behavior, permobil unable to reach a determination as to probable root cause without speculation.Permobil will continue to monitor, and if any new information is received, a follow-up report will be submitted.The dhr was reviewed, and the device was found to have met specification prior to distribution.

• Brand Name: PERMOBIL F3 CORPUS
• Type of Device: 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: 15702059
• MDR Text Key: 302763328
• Report Number: 1221084-2022-00020
• Device Sequence Number: 1
• Product Code: ITI
• UDI-Device Identifier: 17330818676433
• UDI-Public: 17330818676433
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143180
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: Lay User/Patient
• Device Model Number: F3 CORPUS
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/06/2022
• Initial Date FDA Received: 10/31/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/05/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Sex: Prefer Not To Disclose