MAUDE Adverse Event Report: SHENYANG HENYI ENTERPRISE CO., LTD DRIVEMEDICAL; LIFT, PATIENT, NON-AC-POWERED

Model Number	13240
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Vertebral Fracture (4520)
Date of Event	06/17/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive medical was notified of an incident involving a patient lift by the device provider who reported the bolt that secures the cradle to the boom loosened during use and the end user fell resulting in fractured vertebrae.The product's instructions for use state: 'it is extremely important that the lift be inspected before each use.All nuts and bolts should be tight.' as part of its complaint review and evaluation process, drive medical will also notify the manufacturer of the product about this complaint.

• Brand Name: DRIVEMEDICAL
• Common Device Name: LIFT, PATIENT, NON-AC-POWERED
• Manufacturer (Section D): SHENYANG HENYI ENTERPRISE CO., LTD; pump and valve industrial park; no.5 panwu road; yangshigang town, shenyang 11020 0; CH 110200
• MDR Report Key: 25680546
• Report Number: 2438477-2026-00041
• Device Sequence Number: 9709296
• Product Code: FSA
• UDI-Device Identifier: 00822383103709
• UDI-Public: (01)00822383103709
• Combination Product (Y/N): N
• 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): 07/01/2026
• Report Date (Section F): 07/01/2026

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: Health Professional
• Device Model Number: 13240
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/18/2026
• Device Age: 1 YR
• Event Location: Nursing Home
• Date Report to Manufacturer: 07/01/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/01/2026
• 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; Required Intervention
• Patient Sex: Unknown
• Date Report Sent to FDA: 07/01/2026