MAUDE Adverse Event Report: BURKE INC. PACESAVER SCOUT BOSS 4.5; POWER WHEELCHAIR

Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	03/20/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The alleged incident was reported by a dealer servicing the chair.The patient gave conflicting accounts of the incident, that the unit was turned on and that the unit was turned off when she exited the chair.We have tested the joystick that was involved in the incident.The on/off switch works properly.We contacted the joystick/controller manufacturer and confirmed that if the joystick switch is in the off position, the chair cannot move.We believe the patient contacted the joystick and caused the chair to move forward.The owner's manual states, "warning: keep the power button in the off position at all times when stopped or when getting on and off the wheelchair.Sudden accidental movement of the wheelchair will be avoided with the power switch is the off position".There is a comment that the leg riggings do not fit her properly.We believe the chair controls were working properly.The patient, against warnings, did not have the unit turned off when she attempted to exit.Contact was made to the joystick resulting in the wheelchair moving forward causing the incident.Therefore we believe the incident is a result of user error.
Event or Problem Description
It is alleged, the patient stated she was stepping off her footrest with her weight on her right foot and leaned on the armrest to stabilize her and that's when the wheelchair took off.This resulted in a broken leg.

• Brand Name: PACESAVER SCOUT BOSS 4.5
• Common Device Name: POWER WHEELCHAIR
• Manufacturer (Section D): BURKE INC.; 1800 merriam lane; kansas city KS 66106
• MDR Report Key: 8749329
• Report Number: 1919278-2019-00001
• Device Sequence Number: 1668940
• Product Code: ITI
• UDI-Device Identifier: B314823481
• UDI-Public: B314823481
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K023961
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/28/2019

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2019
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/31/2019
• Initial Report FDA Received Date: 07/01/2019
• 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: Required Intervention
• Patient Age: 71 YR
• Patient Weight: 136