MAUDE Adverse Event Report: SHUNLONG HOLDING LTD. DRIVE MEDICAL COMPET II HI/LOHGT ADJ BED W/HRAIL; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number	15571HR
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/16/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive medical was notified of an incident involving an adjustable bed by the end user's wife who reported that the bed rail broke resulting in the end user falling onto the bed rail and hitting his head.The following day the end user was not "acting right" and emergency medical services were contacted, and the end user was taken to the hospital and admitted.Attempts to gather additional information have been unsuccessful.As part of its complaint review and evaluation process, drive medical will also notify the manufacturer of the product about this complaint.

• Brand Name: DRIVE MEDICAL COMPET II HI/LOHGT ADJ BED W/HRAIL
• Common Device Name: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): SHUNLONG HOLDING LTD.; no. 259 jiugan road; sijing town; song jiang district, shanghai 20160 1; CH 201601
• MDR Report Key: 25410504
• Report Number: 2438477-2026-00031
• Device Sequence Number: 21443810
• Product Code: FNL
• UDI-Device Identifier: 00822383963600
• UDI-Public: (01)00822383963600
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 06/05/2026
• Report Date (Section F): 06/05/2026

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: 15571HR
• Device Catalogue Number: 15571HR
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/18/2026
• Event Location: Home
• Date Report to Manufacturer: 06/05/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/05/2026
• 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: 58 YR
• Patient Sex: Male
• Date Report Sent to FDA: 06/05/2026