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

Model Number	RFP4
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	11/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Burke contacted user.User explained preconditions, morbid obesity and weakness in ankles.Incident, wheelchair did not malfunction.User was transferring from wheelchair to recliner.User stated he parked too close to recliner.User stepped out of wheelchair and weak ankle gave out: breaking the ankle.Additionally, user did fall on center column footrest when he fell.No injury from this.User asked the footrest mount be changed to outside mounted footrest which we have done.Wheelchair did not fail in any way.We officially were notified on nov,13 2020 of the incident.We attempted to submit our initial report on dec, 10 2020.The initial report was received by the fda and errored off due to invalid codes being used.Several attempts later we realized the software was not updating even though it was completing and telling us it had updated.We contacted fda esubmitter on january 7 2021 to notify them of our software issue and ask what we should do.We resolved the issue and had to reinstall the software.In our conversation with with the fda esubmitter help desk, we were instructed to submit this as a 30 day report due to the software issues.
Event or Problem Description
User fell and broke ankle while transferring.

• Brand Name: PACESAVER SCOUT
• Common Device Name: POWER WHEELCHAIR
• Manufacturer (Section D): BURKE INC.; 1800 meriiam lane; kansas city KS 66106
• MDR Report Key: 11232022
• Report Number: 1919278-2020-00001
• Device Sequence Number: 19849133
• Product Code: ITI
• UDI-Device Identifier: B314824911
• UDI-Public: B314824911
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K982158
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/26/2021

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: RFP4
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/13/2020
• Initial Report FDA Received Date: 01/26/2021
• 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: Required Intervention
• Patient Age: 60 YR
• Patient Weight: 181