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

Model Number	F5 CORPUS VS
Medical Device Problem Codes	Mechanical Problem (1384); Unintended System Motion (1430); Unintended Movement (3026)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Limb Fracture (4518)
Date of Event	09/26/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the spouse, they and the end-user were out walking in the community while end-user was testing their driving skills.The spouse reports having walked in front of the user (normally to the side) and claims the chair veered to the right, off the sidewalk and down a steep embankment, finally resting in a ditch.Report claims the chair ended up atop the end-user and her foot was trapped beneath the footplate where they reported received an fx to their leg, just above the ankle.The device was reportedly extracted from the ditch and taken to the local service provider for evaluation.At time of this report, permobil has not received any information as to the status of the device, or of the findings during the evaluation.When permobil receives any new information, a follow-up report will be submitted.The dhr was reviewed, and the device was found to have met specifications prior to distribution.
Event or Problem Description
Received report claiming while the end-user was driving down sidewalk in their community, the device allegedly started to veer to right which reportedly caused the end-user to drive off of the sidewalk and into a ditch, resulting in an injury.
Additional Manufacturer Narrative
The device was inspected by permobil representative, with no findings that would indicate the device having malfunctioned.Device was reported to remain fully operational with no notable operational issues.Device was reported to be driving normally with no deviations in drive characteristics as claimed to have occurred.Device has remained in the end-user's custody since the reported event occurrence, and no service has been performed prior to inspection.With information provided, and device being found to remain fully operational with no signs of a malfucntion having occurred.Permobil is unable to reach a determination as to possible root cause of this event without specualtion.

• 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: ivan fernandez ; 300 duke drive; lebanon, TN 37090 ; 8007360925
• MDR Report Key: 17984466
• Report Number: 1221084-2023-00022
• Device Sequence Number: 8398357
• Product Code: IPL
• UDI-Device Identifier: 17330818001006
• UDI-Public: 17330818001006
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2024

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): Initial
• Initial Date Received by Manufacturer: 10/02/2023
• Supplement Date Received by Manufacturer: 10/02/2023
• Initial Report FDA Received Date: 10/23/2023
• Supplement Report FDA Received Date: 03/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/06/2022
• 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