MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION LIKORALL OVERHEAD LIFT; LIFT, PATIENT, NON-AC-POWERED

Model Number	3123001NA
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fall (1848); Hematoma (1884)
Date of Event	12/08/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H11: the device was evaluated onsite by a qualified baxter technician.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.The device underwent functional testing and the problem was unable to be duplicated.The reported condition was not verified.A service history review was performed and revealed that the device has no previous service events; therefore, servicing did not cause or contribute to the reported event.The investigation is currently ongoing, a final report will be submitted upon completion.
Event or Problem Description
It was reported a patient fell during a transfer with a likorall overhead lift and the patient sustained a head injury.During a transfer from the bed to chair the staff heard ¿an unusual noise followed by the rapid descent of the lift strap by approximately six to eight inches.¿ the patient then fell backwards approximately four feet from the lift sling with one leg still trapped in the sling.Allegedly the force of the sudden drop caused the patient to fall through the center opening of the sling, striking their head on the floor.Additionally, the event occurred at ¿0130 and the staff did not turn the light on, so they did not disturb the patient¿.The customer reported that the patient sustained subarachnoid hematoma and was transferred to a trauma center for treatment where the patient was intubated and assessed for potential surgical intervention.The customer reported that given the nature of the subarachnoid hematoma and the patient¿s advanced age, it is likely the patient will be transitioned to comfort measures for end-of-life-care.At this time no additional details regarding the patient outcome have been received.No further information was available at the time of this report.

• Brand Name: LIKORALL OVERHEAD LIFT
• Common Device Name: LIFT, PATIENT, NON-AC-POWERED
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): LIKO AB; nedre vagen 100; lulea, norrbottens lan [se-25] 975 9 2; SW 975 92
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 23969656
• Report Number: 8030916-2026-00001
• Device Sequence Number: 7946859
• Product Code: FSA
• UDI-Device Identifier: 00887761979536
• UDI-Public: (01)00887761979536(11)221228
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/05/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: 3123001NA
• Device Catalogue Number: 3123001NA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2025
• Initial Report FDA Received Date: 01/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Required Intervention; Life Threatening
• Patient Sex: Unknown