MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION UNO 102 EE; LIFT, PATIENT, NON-AC-POWERED

Model Number	2010004
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Pain (1994)
Date of Event	12/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was confirmed that the lift was equipped with a q-link 13 attachment, and the sling bar involved in this event was a liko universal sling bar 450.The q-link 13 and the sling bar will be returned for inspection.Uno 102 mobile lift has electric raising and lowering of the lift arm.Uno mobile lift is intended mainly for use in post acute care facilities like nursing homes and other care homes in the most common lifting situations, for instance, transfers between bed and wheelchair, to and from toilet and for lifting to and from the floor.Uno mobile lift has three alternative height settings, in order always to provide the optimum lifting height.Pain is an unpleasant sensation occurring in varying degrees of severity and typically stops once the stimulus is removed.It is not life threatening, not and do not require treatment to prevent a permanent impairment of a body function or structure.In this event, the patient did not sustain permanent impairment of a body function or permanent damage to a body structure and did not require medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure, therefore, this event will be assessed as non-serious.Additionally, the q-link 13 and the sling bar involved in this case will be returned for inspection.All additional and relevant information received during the course of the inspection will be documented in a final report.
Event or Problem Description
It was reported that with during a transfer from wheelchair to bed using an uno 102 lift and non-liko sling (human care), the sling bar detached, and the patient fell first onto the bed, and then onto the floor.The patient reported pain after the fall, and a red mark was observed on their back.No medical intervention was required.The staff involved in the event did not report any sing of device malfunction.
Additional Manufacturer Narrative
The slingbar and q-link 13 were returned to the manufacturing site for inspection.A visual inspection was performed.The slingbar had scratches and dents on the quick-release hook, which are not considered to be a result of normal wear.The scratches and dents indicate that the quick-release hook has not been correctly attached to the q-link 13.No deviations were observed on the q-link 13.A functional test was performed by attaching the slingbar's quick-release hook to the q-link 13.The test was successful as the slingbar was attached to the q-link 13 without any issues.It was concluded that the likely cause of the reported incident was that the slingbar had been incorrectly attached to the q-link 13.Although there was no serious injury associated with the reported event and the investigation concluded the incident was caused by use error, if the reported incident were to recur, it could lead to serious injury or death.
Event or Problem Description
It was reported that with during a transfer from wheelchair to bed using an uno 102 lift and non-liko sling (human care), the sling bar detached, and the patient fell first onto the bed, and then onto the floor.The patient reported pain after the fall, and a red mark was observed on their back.No medical intervention was required.The staff involved in the event did not report any sing of device malfunction.

• Brand Name: UNO 102 EE
• 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 97592 ; SW 97592
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 21241289
• Report Number: 8030916-2025-00005
• Device Sequence Number: 8605986
• Product Code: FSA
• UDI-Device Identifier: 00887761981775
• UDI-Public: (01)00887761981775
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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,Followup
• Report Date (Section B): 03/07/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: 2010004
• Device Catalogue Number: 2010004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2025
• Supplement Date Received by Manufacturer: 02/18/2025
• Initial Report FDA Received Date: 01/27/2025
• Supplement Report FDA Received Date: 03/07/2025
• 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
• Patient Sex: Unknown