MAUDE Adverse Event Report: SHENYANG HENYI ENTERPRISE CO., LTD DRIVE ULTRALT.PLUSSEMI.ELEC.; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number	15030
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	12/27/2025
Type of Reportable Event	Death
Event or Problem Description
Drive devilbiss healthcare was notified by attorney letter of the presence and potential involvement of a semi-electric bed in a fire, and the end user was injured and subsequently died as the result of a fire.Drive devilbiss healthcare is currently investigating the incident, including attempting to inspect the product through the attorney.An update will be filed if additional information becomes available.
Additional Manufacturer Narrative
The semi-electric bed was inspected by several experts representing several parties.The evaluation confirmed that the semi-electric bed was not the cause of the fire in the reported event.

• Brand Name: DRIVE ULTRALT.PLUSSEMI.ELEC.
• Common Device Name: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): SHENYANG HENYI ENTERPRISE CO., LTD; pump and valve industrial park; no.5 panwu road; yangshigang town, shenyang 11020 0; CH 110200
• MDR Report Key: 24781778
• Report Number: 2438477-2026-00016
• Device Sequence Number: 6132909
• Product Code: FNL
• UDI-Device Identifier: 00822383111094
• UDI-Public: (01)00822383111094
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2026
• Report Date (Section F): 05/12/2026

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: 15030
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/10/2026
• Event Location: Home
• Date Report to Manufacturer: 05/12/2026
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/03/2026
• Supplement Report FDA Received Date: 05/12/2026
• 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: Death
• Patient Sex: Unknown
• Date Report Sent to FDA: 05/12/2026