MAUDE Adverse Event Report: HANGZHOU DUNLI IMPORT & EXPORT DRIVE; BED

Model Number	15030
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	04/18/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare was notified of an incident involving an electric bed by a healthcare provider, who stated that the end user was "sleeping on the hand control when she felt a shock [and] received 3rd degree burn on left hip," for which she was treated with bandages by her home health aides.She reportedly observed rust on two of the screws on the hand control, which may indicate that the hand control was somehow exposed to moisture and compromised.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): HANGZHOU DUNLI IMPORT & EXPORT; no.1 dunli road; renhe street; yuhang, hangzhou 31110 7; CH 311107
• MDR Report Key: 17087727
• Report Number: 2438477-2023-00064
• Device Sequence Number: 6172783
• Product Code: FNL
• UDI-Device Identifier: 00822383111094
• UDI-Public: 00822383111094
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/08/2023
• Report Date (Section F): 06/08/2023

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: 15030
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/10/2023
• Device Age: 5 YR
• Date Report to Manufacturer: 06/15/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/08/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Weight: 102 KG
• Date Report Sent to FDA: 06/08/2023