MAUDE Adverse Event Report: MOTION CONCEPTS LP POWERED WHEELCHAIR SYSTEM

Model Number	BPPS-T-RESR
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Head Injury (1879)
Date of Event	09/05/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
On 06-sep-2019, motion concepts lp was notified by medbloc inc (the motion concepts usa importer) that one of medbloc's dealers (vamc-philadelphia, pa) was notified of an incident that took place on (b)(6) 2019.The dealer reported that the end user stated that he was riding down the road and hit a bump.After hitting the bump, the system "started tilting on its own".He attempted to get out of the system and fell to the ground injuring his head.He stated he and the system were brought to an emergency room where they performed an ekg since he is an existing heart patient.No x-ray to his head or back and no stitches were required.He was sent home with the chair and then contacted us.The end user said that the system display screen indicated that "switch may be stuck".The end user removed the 8-way switch and the user could operate the seating system as intended.

• Brand Name: POWERED WHEELCHAIR SYSTEM
• Common Device Name: WHEELCHAIR
• Manufacturer (Section D): MOTION CONCEPTS LP; 84 citation drive; unit 1-7; concord, L4K3C 1; CA L4K3C1
• MDR Report Key: 9142033
• Report Number: 9615350-2019-00006
• Device Sequence Number: 3123137
• Product Code: ITI
• UDI-Device Identifier: 00754014711413
• UDI-Public: 00754014711413
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K182995
• 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): 10/01/2019

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: BPPS-T-RESR
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2019
• Initial Report FDA Received Date: 10/01/2019
• 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: Other
• Patient Age: 59 YR
• Patient Weight: 145