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

Model Number	F5 VS
Medical Device Problem Codes	Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Skull Fracture (2077); Multiple Fractures (4519)
Date of Event	12/02/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reports received claimed an aide assisting the client had initiated a stand function.Report indicated the chest roll provided with the chair was not being used, but reportedly had incorporated a shoulder harness to hold the end-user in place.Report claims the end-user requested the aide remove the chest harness as it was bothering them.At some point the aide had walked away from the end-user and when they returned noticed the end-user had fallen and was laying on the ground.Reports indicate the following day the end-user was admitted into the hospital where they were diagnosed as having suffered a fractured skull, as well as multiple fractures to their legs and arms.The device was evaluated by the service provider to which it was determined the device was fully operational with no malfunctions being detected.The family did not present any claims nor allegations the device malfunctioned or had any deviation in operation to have contributed to this reported event.All information provided indicates this event being the result of use error by not incorporating the provided chest roll bar which is designed to prevent the end-user from falling forward when standing.Without the chest bar in place, and the report of the aide releasing the chest harness, the end-user had no support for upper body positioning, allowing them fall forward out of the seating when stood.The dhr was reviewed and the device was found to have met specification prior to distribution.
Event or Problem Description
Received report claiming as end-user was in process of performing a stand function, they lost their positioning and fell forward out of the seating to the floor resulting in serious injuries requiring medical intervention.

• Brand Name: PERMOBIL F5 CORPUS VS
• Common Device Name: POWERED WHEELCHAIR
• Manufacturer (Section D): PERMOBIL INC.; 300 duke drive; lebanon TN 37090
• MDR Report Key: 11130850
• Report Number: 1221084-2020-00056
• Device Sequence Number: 677181
• Product Code: ITI
• UDI-Device Identifier: 17330818229844
• UDI-Public: 17330818229844
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 01/07/2021

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 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: 12/10/2020
• Initial Report FDA Received Date: 01/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Weight: 61