MAUDE Adverse Event Report: SHENYANG HENYI ENTERPRISE DRIVE DEVILBISS ULTRA LT FULL ELECTRIC BED; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number	15033BV-FR
Medical Device Problem Code	Temperature Problem (3022)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Drive devilbiss healthcare was notified of an incident involving an electric bed by the caretaker who stated that a fire occurred underneath the bed due to (remote) wires shorting out.Examination of provided pictures, however, shows no evidence of a fire.There was no report or evidence of illness or serious injury associated with the complaint.As part of its complaint review and evaluation process, drive devilbiss healthcare will also notify the manufacturer of the product about this complaint.

• Brand Name: DRIVE DEVILBISS ULTRA LT FULL ELECTRIC BED
• Common Device Name: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): SHENYANG HENYI ENTERPRISE; no. 386, qingnian street; heping district; shenyang city, shenyang ; CH
• MDR Report Key: 22522089
• Report Number: 2438477-2025-00031
• Device Sequence Number: 8078963
• Product Code: FNL
• UDI-Device Identifier: 00822383211732
• UDI-Public: (01)00822383211732
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Report Date (Section B): 07/16/2025
• Report Date (Section F): 07/16/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 15033BV-FR
• Device Catalogue Number: 15033BV-FR
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/25/2025
• Event Location: Home
• Date Report to Manufacturer: 07/16/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/16/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 07/16/2025