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

Model Number 15030

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem Burn(s) (1757)

Event Date 04/18/2023

Event Type  Injury  

Event 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
• Type of Device: BED
• Manufacturer (Section D): HANGZHOU DUNLI IMPORT & EXPORT; no.1 dunli road; renhe street; yuhang, hangzhou 31110 7; CH 311107
• MDR Report Key: 17087727
• MDR Text Key: 316882244
• Report Number: 2438477-2023-00064
• Device Sequence Number: 1
• Product Code: FNL
• UDI-Device Identifier: 00822383111094
• UDI-Public: 00822383111094
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 15030
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/08/2023
• Distributor Facility Aware Date: 05/10/2023
• Device Age: 5 YR
• Date Report to Manufacturer: 06/15/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Weight: 102 KG