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); Hip Fracture (2349)
Date of Event	09/23/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reports received indicate as the end-user was attempting to elevate the seating in effort to reach a higher shelf, they inadvertently activated the stand function by mistake.The end-user reported at the time of the incident, they did not have the required restraints needed for stand (knee block and chest support) in place when the seating started to lift into a standing position.Without the necessary restraints in place, it caused the end-user to lose positioning and fall forward out of the seating to the ground where they were reported to have sustained a fractured hip as a result.The device was evaluated by the local service provider and found to be in full operation with no mechanical or electrical malfunctions having occurred.The end-user reported to his therapist the incident was an inadvertent act.The (b)(6) requested the ability to access the stand feature be removed from the device in efforts to mitigate any chance for recurrence, permobil provided the servicing dealer the necessary components to replace which disables he ability to access the stand feature.The dhr was reviewed and the device was found to have met specification prior to distribution.
Event or Problem Description
Received report claiming the end-user having inadvertently activating the stand function of the device without having any support measures in place.This action caused the end-user to lose positioning in the seating and fall to the floor where they sustained an injury 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: 10677448
• Report Number: 1221084-2020-00048
• Device Sequence Number: 3065830
• Product Code: ITI
• UDI-Device Identifier: 17330818001006
• UDI-Public: 17330818001006
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 10/14/2020

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: 09/24/2020
• Initial Report FDA Received Date: 10/14/2020
• 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: 100