MAUDE Adverse Event Report: BLISS HEALTH PRODUCTS CO. LTD DRIVE DEVILBISS HEALTHCARE; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number	15201BV
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Laceration(s) (1946); Limb Fracture (4518)
Date of Event	09/11/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare was notified of an incident involving a bed by the provider who reported the bedrail "popped off" and the end user fell out of the bed during personal care.The end user was admitted to the hospital with fractures to their femur and tibia bones and lacerations to both legs that required skin grafts.Based on our investigation, it appears that the customer used a bed rail that was incompatible with the bed.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): BLISS HEALTH PRODUCTS CO. LTD; no.61 &96 zhaoyi road; dongsheng town; zhongshan city, guangdong 52841 4; CH 528414
• MDR Report Key: 20421759
• Report Number: 2438477-2024-00054
• Device Sequence Number: 18242900
• Product Code: FNL
• UDI-Device Identifier: 00822383143026
• UDI-Public: 00822383143026
• 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): 10/10/2024
• Report Date (Section F): 10/11/2024

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: 15201BV
• Device Catalogue Number: 15201BV
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/17/2024
• Event Location: Home
• Date Report to Manufacturer: 10/11/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/10/2024
• 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: Hospitalization
• Patient Age: 71 YR
• Patient Sex: Female
• Date Report Sent to FDA: 10/11/2024