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

Model Number	3122005
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Codes	Laceration(s) (1946); Limb Fracture (4518)
Date of Event	11/10/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that one of the sling bar latches was missing on a likorall overhead lift and the patient fell sustaining an injury.The patient sustained a "broke their arm and gashed their forehead".Follow up was performed with the customer and the customer was not willing to share any details of the event (injury, medical intervention or patient outcome).There was no medical intervention reported.However, based on the nature of the injuries reported, medical or surgical intervention was likely required to prevent permanent impairment of a body function or permanent damage to a body structure.The baxter service technician inspected the lift and found that the sling bar on the lift was missing a latch.The technician replaced the latch, and the device is working as intended.No further information was available at the time of this report.
Additional Manufacturer Narrative
H11: the actual device was not able to be returned; however, a baxter technician performed an on-site evaluation of the device.During visual inspection a clip on the sling bar was observed to be missing.The reported condition was verified.The cause of the condition could not be determined.However, the instructions for use state "before lifting, always make sure that the latches are intact; missing or damaged latches must always be replaced.To correct the issue the technician replaced the clip.For trouble-free use, certain details should be checked each day the lift is used: check the functionality of the latches." 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.Should additional relevant information become available, a supplemental report will be submitted.

• 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: 23751458
• Report Number: 8030916-2025-00144
• Device Sequence Number: 9520733
• Product Code: FSA
• UDI-Device Identifier: 00887761979710
• UDI-Public: (01)00887761979710
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 12/08/2025

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: 3122005
• Device Catalogue Number: 3122005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/10/2025
• Initial Report FDA Received Date: 12/08/2025
• 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
• Patient Sex: Unknown