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

Model Number F5 CORPUS VS

Device Problems Mechanical Problem (1384); Mechanical Jam (2983); Insufficient Information (3190)

Patient Problems Bone Fracture(s) (1870); Multiple Fractures (4519)

Event Date 11/23/2020

Event Type  Injury  

Manufacturer Narrative

Permobil received reports that an incident occurred (over 1 year ago), where the user was operating the wheelchair in outdoor environment at fallen park trail way when the wheelchair came to a sudden stop and overturned resulting in the user sustaining serious injury.Permobil only recently has been made aware of this reported failure and have not yet been able to inspect the device or understand the exact circumstances surrounding this event.Investigation is still ongoing.Upon examination of the wheelchair and attempts made to identify root cause, a follow-up report will be submitted and will contain any missing information not contained in this report.The dhr for this device has been reviewed and the wheelchair met specification prior to distribution.

Event Description

Received reports that 3 days before thanksgiving 2020 (last year) at fallen park trail way, the wheelchair decided to lock up and stop instantly flipping forward with the end-user in it.As a result, the user fell out of the wheelchair and onto their knee and leg sustaining broken femur, acl, mcl and patella on the inside of the leg.

Manufacturer Narrative

Device was evaluated by permobil representative and found to remain fully operational with no notable electrical or mechanical issues.The end-user reported the event of sudden stoppage occurred approximately 1 year prior and they have not had any recurring behavior since the day of event.Review of system error log did not have any registers that would indicate a system error having occurred to which this reported event can be attributed.Due to the timespan of 1 year since event occurred, and reports of device remaining operational and in use during that timespan without any recurrence.Permobil cannot confirm a failure occurred thus unable to reach a determination as to possible root cause without speculation.Permobil informed the end-user of the necessity to notify their service provider as soon as possible of any abnormalities and to refrain from utilizing the device until evaluation/service activities have been completed.

• Brand Name: PERMOBIL F5 CORPUS VS
• 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: 13015102
• MDR Text Key: 287394460
• Report Number: 1221084-2021-00043
• Device Sequence Number: 1
• Product Code: IPL
• UDI-Device Identifier: 17330818001006
• UDI-Public: 17330818001006
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191874
• 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,Followup
• Report Date: 02/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: F5 CORPUS VS
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/31/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/20/2016
• 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: Male
• Patient Weight: 91 KG