MAUDE Adverse Event Report: LERADO ZHONGSHAN PEACEFUL COVE BUSINESS DRIVE; POWER CHAIR

Model Number	SFPRO317FS-21
Medical Device Problem Codes	Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hip Fracture (2349)
Date of Event	04/18/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss was notified of an incident involving a power chair by distributor, who reported receiving a complaint from an end user that while the end user seated on the unit and reaching to put something in the refrigerator, the unit tipped over.She was taken by ambulance to the hospital, broke her hip in 3 places and had surgery.The unit was returned to drive for evaluation, where it was determined to be working as intended, with no apparent defect.The owner's manual specifically warns as follows: "do not stretch your body out on the scooter.Such action may cause you to lose your balance or be injured.".

• Brand Name: DRIVE
• Common Device Name: POWER CHAIR
• Manufacturer (Section D): LERADO ZHONGSHAN PEACEFUL COVE BUSINESS; 26, guangfu rd,; dong sheng town; zhongshan, guangdong, 52841 4; CH 528414
• MDR Report Key: 14977976
• Report Number: 2438477-2022-00047
• Device Sequence Number: 14860571
• Product Code: INI
• UDI-Device Identifier: 00822383991771
• UDI-Public: 822383991771
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/11/2022
• Report Date (Section F): 07/11/2022

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: SFPRO317FS-21
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2022
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/21/2022
• Device Age: 3 MO
• Event Location: Home
• Date Report to Manufacturer: 05/25/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/11/2022
• 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: 76 YR
• Patient Sex: Unknown
• Patient Weight: 113 KG
• Date Report Sent to FDA: 07/11/2022