MAUDE Adverse Event Report: NANTONG SHUNLONG PHYSICAL THERAPY CO.,LTD DRIVE MEDICAL COMPET HI/LO HGT ADJ BED W/HRAIL; BED,AC-POWERED ADJUSTABLE HOSPITAL,PRODUCT CODE:FNL

Model Number	15571HR
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/16/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
1.Device evaluation status the subject failed medical bed device was not returned to the manufacturer for failure analysis and technical evaluation.No further supporting information related to this adverse event could be obtained from the distributing partner.2.Batch traceability review the initial reporting entity, drive medical, only provided the serial number (sn) of the complete hospital bed unit.The bed side rails are affixed with separate standalone serial number labels independent of the main bed frame.As a result, the corresponding production lot (po/lot) of the involved side rail component cannot be accurately cross-referenced against the main bed serial number record.Due to the unavailability of the physical side rail unit and its matching serial number label, the manufacturer is currently unable to confirm whether this specific side rail component was manufactured by shunlong.3.Follow-up arrangement the manufacturer shunlong will continue to closely monitor this adverse event.We will actively follow up with drive medical and relevant distributors to collect any newly released information related to the incident, complete full traceability verification once additional serial number or production lot records become available, and conduct comprehensive internal review to identify potential risks of similar bed rail components.Any updated investigation findings will be submitted to fda in a timely manner per mdr reporting requirements.
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 HI/LO HGT ADJ BED W/HRAIL
• Common Device Name: BED,AC-POWERED ADJUSTABLE HOSPITAL,PRODUCT CODE:FNL
• Manufacturer (Section D): NANTONG SHUNLONG PHYSICAL THERAPY CO.,LTD; no 88,yangcheng road,wuyao; town,rugao city; nantong, jiangsu 22653 3; CH 226533
• Manufacturer (Section G): NANTONG SHUNLONG PHYSICAL THERAPY EQUIPMENT CO.,LT; no.88 yangcheng road,wuyao; town,rugao city; nantong, jiangsu 22653 3; CH 226533
• Manufacturer Contact: rita liu ; no.88 yangcheng road,wuyao town; rugao city; nantong, jiangsu 22653-3 ; CH 226533
• MDR Report Key: 25664948
• Report Number: 3008951110-2026-00001
• Device Sequence Number: 18743518
• Product Code: FNL
• UDI-Device Identifier: 00822383963600
• UDI-Public: (01)00822383963600
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial
• Report Date (Section B): 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/08/2026
• Initial Report FDA Received Date: 06/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 58 YR
• Patient Sex: Male