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

Model Number	F5 CORPUS VS
Medical Device Problem Code	Installation-Related Problem (2965)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Multiple Fractures (4519)
Date of Event	07/11/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Received report claiming while the end-user was in process of performing a stand function, claims having received injuries to their feet requiring medical intervention to address.
Additional Manufacturer Narrative
Report claims while the end-user was initially using the stand feature, claims to have sustained fractures to both heels of their feet.No claims or allegations of the device having malfunctioned in any way to have contributed to this event.Inspection of the device found it to remain fully operational, with no mechanical or electrical issues being found.It was however found the footplates of the seating to have been adjusted where the footplate angle was in a dorsiflexion (toes angled upward) position so when the end-user stood, their weight was shifted to the heels as opposed to the flat of the foot.The footplates are designed to be adjusted to various angles to meet the specific needs for the end-user's physical characteristics.It is permobil's contention this reported event was caused by the service provider delivering the device that was improperly adjusted for the user.The dhr was reviewed, and the device was found to have met specification prior to distribution.

• 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: 18118298
• Report Number: 1221084-2023-00024
• Device Sequence Number: 7512124
• Product Code: IPL
• UDI-Device Identifier: 17330818001006
• UDI-Public: 17330818001006
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): Y
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/13/2023

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: 10/17/2023
• Initial Report FDA Received Date: 11/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2023
• 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