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

Model Number	2010004
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	10/27/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was received for evaluation.A device evaluation was performed, and it was noted that the reported issue was verified.The cause of the reported condition could not be determined.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.
Event or Problem Description
During the transfer of a patient to a bed using an uno mobile patient lifting system, the hook (connecting the slingbar to the lift arm) came off.The hook hit the patient on the forearm as it dropped and caused the patient to fall a short distance on to the mattress of the bed.The patient was not injured from the fall, however, sustained a 15cm laceration to the forearm from the hook.The injury was cleaned and then closed with sutures, and a sling was applied.An x-ray confirmed no fracture.No additional information was available.

• Brand Name: UNO MOBILE 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: 23934131
• Report Number: 8030916-2025-00150
• Device Sequence Number: 15859904
• Product Code: FSA
• UDI-Device Identifier: 00887761981775
• UDI-Public: (01)00887761981775
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/31/2025

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: 2010004
• Device Catalogue Number: 2010004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/03/2025
• Initial Report FDA Received Date: 12/31/2025
• 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