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.There is no indication that a serious injury occurred.
Additional Manufacturer Narrative
The investigation is still ongoing.The results will be udpated in next report.
Additional Manufacturer Narrative
The involved lift was inspected.The investigation is ongoing.Results of the analysis will be provided to the follow-up report.
Additional Manufacturer Narrative
Report was submitted to update the information related to the resident's outcome and type of report.The investigation is ongoing.Results of the analysis will be provided to the follow-up report.
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.
Additional Manufacturer Narrative
The sara plus floor lift was inspected by an arjo representative.During the inspection identified an electrical failure in the device's printed circuit board (pcb), it was shorted out.According to the device design, in the unlikely event that the hand control or dual control panel fails to operate the lift (e.G.Due to a pcb failure, as in the analysed case), while a patient is still supported by the sling, a manual lowering option is available.This can be activated using the ¿lower override knob¿ located on the right-hand side of the main cover.Step-by-step instructions for using this function are provided in the sara plus instructions for use (kkx52180m-en_23).This feature allows caregivers to manually lower the lift with the resident in case of a system failure or power loss, ensuring the resident can be safely repositioned.In the analysed case, it was reported that the resident¿s body position allegedly obstructed access to the "lower override knob" (named by customer as ¿safety release button¿).According to ifu, before initiating any transfer, the ifu emphasizes the need to ¿carefully push the lift closer to make full lower leg contact with the proactive pad¿ and assess whether ¿the patient requires the lower leg straps¿.Failure to ensure this contact and stabilization may result in the patient slipping or assuming an unstable posture during the lift.Additionally, according to ifu ¿before attempting to use sara plus, a full clinical assessment of the resident\patient condition and suitability must be carried out by a qualified person.¿ the incident was caused by a sequence of events, an electrical failure in the lift¿s pcb resulted in a lift stall during transfer, the resident¿s positioning obstructed emergency lowering access and probably led to unstable posture.Finally, the lift shifted and rolled over the resident¿s foot as the legs slipped underneath.The device failed to meet its specifications due to the pcb malfunction.The device was in use when the event occurred, and the complaint was deemed reportable due to foot entrapment resulting in 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 PL-62 052; PL PL-62052
• Manufacturer (Section G): ARJOHUNTLEIGH POLSKA SP. Z O.O.; ul. ks. piotra wawrzyniaka 2; komorniki PL-62 052; PL PL-62052
• Manufacturer Contact: justyna kielbowska ; ks. wawrzyniaka 2; komorniki 62-05-2 ; PL 62-052 ; 883337089
• MDR Report Key: 22331064
• Report Number: 3007420694-2025-00155
• Device Sequence Number: 9483093
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/04/2025

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
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2025
• Supplement Date Received by Manufacturer: Not provided; 07/23/2025; Not provided
• Initial Report FDA Received Date: 06/25/2025
• Supplement Report FDA Received Date: 07/22/2025; 07/25/2025; 08/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/18/2023
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male