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

Model Number	F5 CORPUS VS
Medical Device Problem Codes	Mechanical Problem (1384); Mechanical Jam (2983); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Multiple Fractures (4519)
Date of Event	11/23/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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
• 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: 13015102
• Report Number: 1221084-2021-00043
• Device Sequence Number: 14749645
• Product Code: IPL
• UDI-Device Identifier: 17330818001006
• UDI-Public: 17330818001006
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K191874
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/11/2022

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: F5 CORPUS VS
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2021
• Supplement Date Received by Manufacturer: 01/31/2022
• Initial Report FDA Received Date: 12/15/2021
• Supplement Report FDA Received Date: 02/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/20/2016
• 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: Male
• Patient Weight: 91 KG