MAUDE Adverse Event Report: PERMOBIL INC. PERMOBIL F3 CORPUS; POWERED WHEELCHAIR

Model Number	F3 CORPUS
Medical Device Problem Codes	Mechanical Problem (1384); Unintended Movement (3026); Device Fell (4014)
Health Effect - Clinical Code	Brain Injury (2219)
Date of Event	07/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The end-user described having pulled in forward (facing vehicle) on the platform lift, and while lifting the platform off the ground, they described hearing a "click" and the chair rolled backwards.The end-user claims the protective flap at the end-of the platform did not stop the chair from rolling off the end where they described falling approximately 2-2.5 feet to the ground.End-user stated the device landed and rested on the headrest and rear suspension arms.End-user reported having been admitted to the hospital where they were diagnosed as having sustained a brain contusion.Permobil representatives inspected the device, finding it fully operational with no indications of a device failure having occurred.Permobil was unable to recreate the reported involuntary movement as described and the end-user reported the device had not had any recurring issues after that initial event.The end-user reports having left the device powered on while on the platform.Permobil recommended the device should be powered off when on a lift to avoid the potential for accidental activation of drive controls.Permobil was unable to confirm a device failure having occurred and is unable to determine a root cause without speculation.The dhr was reviewed, and the device was found to have met specification prior to distribution.
Event or Problem Description
While end-user was in process of using a vertical platform lift installed on their van, they reportedly heard the electric brake "click" and the device rolled backwards, off the platform, falling approximately 2-2.5' to the ground which resulted in injuries to the end-user requiring hospitalization.

• Brand Name: PERMOBIL F3 CORPUS
• Common Device Name: POWERED WHEELCHAIR
• Manufacturer (Section D): PERMOBIL INC.; 300 duke drive; lebanon TN 37090
• MDR Report Key: 12416701
• Report Number: 1221084-2021-00029
• Device Sequence Number: 14547352
• Product Code: ITI
• UDI-Device Identifier: 17330818676433
• UDI-Public: 17330818676433
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K143180
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/02/2021

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: F3 CORPUS
• 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: 08/12/2021
• Initial Report FDA Received Date: 09/02/2021
• 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