MAUDE Adverse Event Report: PERMOBIL AB (PAB) PERMOBIL F5 CORPUS; POWERED WHEELCHAIR

Model Number F5 CORPUS

Device Problems Unintended Collision (1429); Unintended Movement (3026)

Patient Problems Bone Fracture(s) (1870); Limb Fracture (4518)

Event Date 11/12/2021

Event Type  Injury  

Event Description

Permobil ab received report claiming while the end-user was driving their device out-of-doors, the device reportedly struck a curbside which caused the device to stop abruptly.The sudden stoppage reportedly caused the end-user to lose positioning and fall out of the seating to the ground where it was reported they sustained serious injury requiring medical intervention.

Manufacturer Narrative

Information provided to permobil ab from the service provider claim as the end-user was operating their power wheelchair out-of-doors on a local street, the device reportedly maneuvered into a curb side.It was reported upon impact, the device abruptly stopped, forcing the end-user to lose positioning and fall to the ground where they were reported to have sustained a broken ankle.The end-user could not provide any information as to what may have led to impacting the curb, nor was any claim or allegation made that the permobil device malfunctioned or deviated in operation to have contributed to the event.Permobil technicians inspected the device and found it to remain fully operational with no signs of electrical or mechanical issues that may have contributed to this event.As device was fully operational with no signs of a previous malfunction having occurred, it is permobil ab's contention that the most likely cause of the event was user error in maneuvering the power wheelchair into a curb side that is higher than what the device was designed to accommodate.The dhr was reviewed, and the device was found to have met specification prior to distribution.

• Brand Name: PERMOBIL F5 CORPUS
• Type of Device: POWERED WHEELCHAIR
• Manufacturer (Section D): PERMOBIL AB (PAB); per uddens vag 13; timra, 86123 ; SW 86123
• Manufacturer (Section G): PERMOBIL AB (PAB); per uddens vag 20; timra, 86123 ; SW 86123
• Manufacturer Contact: kevin bullock ; 300 duke drive; lebanon, TN 37090 ; 8007360925
• MDR Report Key: 13232473
• MDR Text Key: 287345220
• Report Number: 1221084-2022-00001
• Device Sequence Number: 1
• Product Code: ITI
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K143014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/12/2022

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: F5 CORPUS
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/14/2021
• Initial Date FDA Received: 01/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/23/2017
• 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