MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP. Z O.O. SARA PLUS; LIFT, PATIENT, NON-AC-POWERED

Model Number	HEP1001-US
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Movement Disorder (4412)
Date of Event	05/27/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that while using the sara plus floor lift, the lift stalled, causing the resident's legs to buckle and the resident to hang suspended by the safety strap.The weight of the device pressed down on the right knee.The lift shifted and rolled over the resident's foot as the legs slipped underneath.Due to the resident's body position, the caregiver could not access the safety release button.The event resulted in a cut on a diabetic foot and redness on the resident's knee.The resident's outcome was assessed by the clinical specialist as a serious injury.

• Brand Name: SARA PLUS
• Common Device Name: LIFT, PATIENT, NON-AC-POWERED
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP. Z O.O.; ul. ks. piotra wawrzyniaka 2; komorniki, 62-05 2; PL 62-052
• MDR Report Key: 22606876
• Report Number: 1419652-2025-00044
• Device Sequence Number: 5443735
• Product Code: FSA
• UDI-Device Identifier: 05055982787451
• UDI-Public: (01)05055982787451(11)230718
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/25/2025
• Report Date (Section F): 07/25/2025

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: Other
• Device Model Number: HEP1001-US
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/23/2025
• Device Age: 1 YR
• Event Location: Home
• Date Report to Manufacturer: 07/25/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/25/2025
• 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: Other
• Patient Sex: Male
• Date Report Sent to FDA: 07/25/2025