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	11/06/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation revealed that the root cause of this failure mode is contributed to "improper use - device interface".The patient reported driving 7.5 mph (top speed) when his two dogs came around the corner.The patient reported that they tried to avoid running over his dog and took a hard-left turn.The patient reported that because he was not wearing a positional belt as required when occupying the device, he fell from the seating system and broke his leg (tibia bone).The patient reported that the wheelchair did not cause or contribute to this event.The wheelchair was returned to permobil in a fully stood up seat position with mechanics under the seating system that allow stand, tilt and elevation was bent from an external source causing the seat frame to be stuck in a stand position unable to operate.As far as the rest of the wheelchair, no additional damages could be found.The damages done to the seating system cannot be explained or linked to the event described.When questioning the patient, a reason could not be given for this damage.In an attempt to prevent improper use, the patient was informed to always wearing a positional belt when using the device and to always report damages immediately when they occur and stop using the device until approved by a certified technician.The dealer was supplied the spare parts needed to repair the wheelchair back to factory specification.The dhr for this device was reviewed and the wheelchair met specification prior to distribution.
Event or Problem Description
Patient stated that he was traveling full speed and to avoid the dog took a hard left turn and fell out of the wheelchair, having not been wearing a positional belt.End user stated that the device did not tip over or sustain damages during the event.The patient is reported to have broke his leg.

• Brand Name: PERMOBIL F5
• Common Device Name: POWERED WHEELCHAIR
• Manufacturer (Section D): PERMOBIL INC.; 300 duke drive; lebanon TN 37090
• MDR Report Key: 7115281
• Report Number: 1221084-2017-00102
• Device Sequence Number: 1874291
• Product Code: ITI
• UDI-Device Identifier: 17330818229844
• UDI-Public: 17330818229844
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 12/13/2017

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2017
• Initial Report FDA Received Date: 12/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 104