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

Model Number	15021BV-LW
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/02/2024
Type of Reportable Event	Death
Event or Problem Description
Drive devilbiss healthcare was notified of an incident involving a bed rail by the provider who stated that the end user was having nursing care done when the bed rail collapsed and broke, and the end user fell to the floor.The end user was admitted to the hospital and expired a week or two later, however no cause of death was reported.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): SHYNLONG HOLDING, LTD.; no 259 jiugan road; sijing town,songjiang district, shanghai 20160 0; CH 201600
• MDR Report Key: 20202502
• Report Number: 2438477-2024-00048
• Device Sequence Number: 18038225
• Product Code: FNL
• UDI-Device Identifier: 00822383007694
• UDI-Public: 00822383007694
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 09/12/2024
• Report Date (Section F): 09/12/2024

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: 15021BV-LW
• Device Catalogue Number: 15021BV-LW
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/21/2024
• Event Location: Home
• Date Report to Manufacturer: 09/12/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/12/2024
• 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: Death
• Patient Sex: Male
• Date Report Sent to FDA: 09/12/2024