MAUDE Adverse Event Report: SHENYANG HENYI ENTERPRISE CO. DRIVE DEVILBISS HEALTHCARE; LIFT, PATIENT, NON-AC-POWERED

Model Number	13023SV
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Bruise/Contusion (1754); Vertebral Fracture (4520)
Date of Event	10/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare was notified of an incident involving a patient lift by the end user's daughter who stated the end user's caretaker was attempting to transfer the end user in the lift when the lift fell on top of the patient.The end user's daughter stated that the caretaker was using the lift to move the end user further than she should have been, and also noticed that the back left caster assembly was not swiveling properly, however it is unclear what caused the lift to tip over.Product labeling states that the "lift is not a transport device.It is intended to transfer an individual from one resting surface to another (such as a bed to a wheelchair).Moving a person suspended in a sling over any distance is not recommended." the end user sustained a fracture in her neck and bruising to her face and was admitted to the hospital and rehabilitation for 3 months.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: LIFT, PATIENT, NON-AC-POWERED
• Manufacturer (Section D): SHENYANG HENYI ENTERPRISE CO.; no.386-3 qingnian st.; heping dist.; shenyang, 11000 4; CH 110004
• MDR Report Key: 19818548
• Report Number: 2438477-2024-00039
• Device Sequence Number: 8684457
• Product Code: FSA
• UDI-Device Identifier: 00822383135441
• UDI-Public: 00822383135441
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 07/24/2024
• Report Date (Section F): 07/24/2024

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: Other
• Device Model Number: 13023SV
• Device Catalogue Number: 13023SV
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2024
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/03/2024
• Event Location: Home
• Date Report to Manufacturer: 07/24/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/24/2024
• 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: 79 YR
• Patient Sex: Female
• Date Report Sent to FDA: 07/24/2024