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

Model Number	F5
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	01/12/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reports provided by the end-users family member claim as the end-user was upstairs on the second story of their home, they maneuvered their device too close to the stairwell entrance which allowed one of the wheels to drop off the edge of the upper step.This resulted in the device becoming unstable and falling approximately 15 steps to the bottom landing.Reports indicate the end-user was admitted to the hospital having received multiple broken bones, but the specifics and extent of injuries were not provided.The service provider reports the device remains fully operational in both seat functions and drive maneuverability, having sustained relatively minor damages as a result of the fall.Provider reports interviews with the end-user and family indicate this event was a judgement error by the end-user and no allegations or claims were made of a device malfunction or error having contributed to this event.The dhr was reviewed and device met specification prior to distribution.
Event or Problem Description
Received report claiming end-user having inadvertently maneuvered their device over the top edge of a stairwell falling approximately 15 steps to the bottom.End-user reported to have suffered significant injuries requiring medical attention.

• Brand Name: PERMOBIL F5
• Common Device Name: POWERED WHEELCHAIR
• Manufacturer (Section D): PERMOBIL INC.; 300 duke drive; lebanon, tn
• MDR Report Key: 9708586
• Report Number: 1221084-2020-00007
• Device Sequence Number: 14321409
• Product Code: ITI
• UDI-Device Identifier: 17330818229844
• UDI-Public: 17330818229844
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K143180
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/13/2020

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
• 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: 01/16/2020
• Initial Report FDA Received Date: 02/13/2020
• 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: 102