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

Model Number	15030
Medical Device Problem Code	Device Slipped (1584)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/10/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare received a letter from an attorney representing an end user, which alleged that a delta pro bed "slipped," causing the end user to fall and sustain significant injuries.The attorney did not specify the injuries in the letter.Drive is currently attempting to inspect the product in cooperation with the attorney.Drive will file an update as soon as additional information becomes available.

• Brand Name: DRIVE DEVILBISS HEALTHCARE
• Common Device Name: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): SHUNLONG HOLDING LTD; 259 juigan road; sijing town,songjiang district, shanghai 20016 00; CH 2001600
• MDR Report Key: 18537950
• Report Number: 2438477-2024-00003
• Device Sequence Number: 17811550
• Product Code: FNL
• UDI-Device Identifier: 00822383111094
• UDI-Public: 00822383111094
• 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): 01/18/2024
• Report Date (Section F): 01/18/2024

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
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/28/2023
• Event Location: Home
• Date Report to Manufacturer: 01/18/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/18/2024
• 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: Female
• Date Report Sent to FDA: 01/18/2024