MAUDE Adverse Event Report: SHUNLONG HOLDING LTD. DRIVE DEVILBISS HEALTHCARE; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number	15571HR
Medical Device Problem Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Codes	Partial thickness (Second Degree) Burn (2694); Full thickness (Third Degree) Burn (2696)
Date of Event	03/17/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare was notified of an incident involving a bed by a letter from an attorney, stating that the end user was in bed when the motor of the bed and mattress allegedly caught on fire, causing second and third degree burns to their legs.There was no further information provided.Drive will cooperate and participate in the litigation process to gather further information as to the origin and cause of the fire.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 HEALTHCARE
• Common Device Name: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): SHUNLONG HOLDING LTD.; 2, floor 2, building 2, nanyue; wutian sub-district,; ouhai district wenzhou,, zhejiang 32500 0; CH 325000
• MDR Report Key: 21208827
• Report Number: 2438477-2025-00006
• Device Sequence Number: 3810355
• Product Code: FNL
• UDI-Device Identifier: 00822383963600
• UDI-Public: (01)00822383963600
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 01/22/2025
• Report Date (Section F): 01/22/2025

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: 15571HR
• Device Catalogue Number: 15571HR
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/06/2025
• Event Location: Home
• Date Report to Manufacturer: 01/22/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/22/2025
• 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 Sex: Male
• Date Report Sent to FDA: 01/22/2025