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	11/17/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Service provider reported having received communication from the end-user that they had suffered a fracture to their tibia (no mention as to left or right) to which they allege occurred while using the chair to perform a stand function.According to the service provider, the end-user believes this incident may have occurred when the device was being set up upon initial delivery.The service provider and permobil representative were present at the initial delivery/set up of the device, both reporting of nothing abnormal having occurred during the set-up, nor the end-user bringing anything to their attention during the set-up process.At this time, it is unclear how or when the reported injury occurred as the device is reported to be fully operational.The service provider is still gathering information from the end-user and is scheduling with end-user to inspect the device and re-evaluate possible positioning needs.If any further pertinent information is received, a follow-up report will be submitted.The dhr was reviewed and device met specification prior to distribution.
Event or Problem Description
Received report of end-user alleging having suffered a fractured tibia after performing a stand function with the chair.

• Brand Name: PERMOBIL F5
• Common Device Name: POWERED WHEELCHAIR
• Manufacturer (Section D): PERMOBIL INC.; 300 duke drive; lebanon TN 37090
• MDR Report Key: 7146477
• Report Number: 1221084-2017-00106
• Device Sequence Number: 1275569
• Product Code: ITI
• UDI-Device Identifier: 17330818229844
• UDI-Public: 17330818229844
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K143014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 12/26/2017

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
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2017
• Initial Report FDA Received Date: 12/26/2017
• 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: 64