MAUDE Adverse Event Report: SHENYANG HENYI ENTERPRISE CO. DRIVE; BED

Model Number	15030BV-HR
Medical Device Problem Codes	Overheating of Device (1437); Material Deformation (2976)
Health Effect - Clinical Codes	Burn(s) (1757); Tissue Breakdown (2681)
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare was notified of an incident involving an electric bed, which is intended to be used as one component of a comprehensive, multi-disciplinary pressure injury management program.The end user of the bed stated that "he was injured and developed breakdown and has an open wound on his back" the end user did not seek medical attention.Drive did not receive any information regarding the patient's overall pressure injury management program.Drive is currently investigating the incident, including attempting to retrieve the product and inspect it, and will file an update if additional information becomes available.

• Brand Name: DRIVE
• Common Device Name: BED
• Manufacturer (Section D): SHENYANG HENYI ENTERPRISE CO.; no.386-3 qingnian st.; heping dis., shenyang liaoning 11000 4; CH 110004
• MDR Report Key: 16388739
• Report Number: 2438477-2022-00137
• Device Sequence Number: 5605209
• Product Code: FNL
• UDI-Device Identifier: 00822383211534
• UDI-Public: 00822383211534
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/07/2023
• Report Date (Section F): 02/07/2023

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: 15030BV-HR
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/26/2022
• Device Age: 2 YR
• Date Report to Manufacturer: 02/14/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/16/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Male
• Date Report Sent to FDA: 02/07/2023