MAUDE Adverse Event Report: DRIVE; LIFT, PATIENT, NON-AC-POWERED

Model Number	13224XL
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Hip Fracture (2349)
Date of Event	11/26/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare was notified of an incident involving a patient lift sling via a provider's voluntary medwatch report, which stated the sling on a patient lift broke during transport, causing the patient to fall to the floor and sustain a hip fracture.The report did not identify how the sling broke, and efforts to contact the provider to gather additional information have been unsuccessful.As part of its complaint review and evaluation process, drive devilbiss healthcare will also notify the manufacturer of the product about this complaint if the manufacturer can be identified.

• Brand Name: DRIVE
• Common Device Name: LIFT, PATIENT, NON-AC-POWERED
• MDR Report Key: 21293241
• Report Number: 2438477-2025-00009
• Device Sequence Number: 9208052
• Product Code: FSA
• UDI-Device Identifier: 00822383109404
• UDI-Public: (01)00822383109404
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 02/03/2025
• Report Date (Section F): 02/03/2025

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: 13224XL
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/07/2025
• Event Location: Home
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/03/2025
• 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 Age: 89 YR
• Patient Sex: Female
• Patient Weight: 112 KG
• Patient Race: White
• Date Report Sent to FDA: 02/03/2025