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 Codes	Pain (1994); Vertebral Fracture (4520)
Date of Event	10/03/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that as a patient was being transferred from his bed to a wheelchair using the uno 102 lift, the lift¿s ¿jumper¿ (slingbar) detached at the quick release while the patient was hanging in the lift.The patient fell down to the edge of the bed and then slid down the side of the bed to the floor.As the patient slid down, he hit his head on the edge of the bed.It is noted that the patient was alert and talkative following the fall but was subsequently taken to the hospital by ambulance due to ¿pain.¿ the patient was provided oxygen and a ct of the brain, cervical spine, and lumbar spine was performed which found a ¿slight compression in the l3 vertebrae, the brain and cervical spine were noted to be unremarkable.It is noted the oxygen was ¿phased out¿ and the patient¿s pain was treated with buprenorphine patch which was later changed to ¿oxynorm and ultimately norgesic and alvedon.¿ the patient was reported to have free mobilization when discharged home to his healthcare center.
Additional Manufacturer Narrative
The sling bar and q-link 13 was inspected at the manufacturing site on.There was no problem with the sling bar or q-link 13.The products were functioning as designed, where the sling bar could be attached to the q-link 13 without any issues this issue is determined to be caused by user error (incorrect attachment of sling bar to q-link 13).The customer has been offered additional training on how to correctly use the medical device.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.Universal slingbar can be used in combination with liko slings that attaches to the sling bar using sling loops.Liko´s universal sling bars are with two assembly options, fixed assembly or with quick-release hook.The device ifu states: "for trouble-free use, certain details should be checked before each use.¿ when using a quick-release hook system, check that the quick-release hook is correctly fastened to the lift and the sling bar.¿ before lifting, check that the lifting accessory hangs vertically and can move freely." in this event, the patient reportedly experienced pain and ¿slight compression¿ of the l3 vertebrae.Although no fracture was specifically reported, it is reasonable to conclude the patient sustained a compression fracture of the l3 vertebrae.Medical intervention included prescription analgesics for the reported pain, with no intervention reported for the l3 compression fracture.Pain is an unpleasant sensation occurring in varying degrees of severity and typically stops once the stimulus is removed.Pain may be contained to a discrete area as in an injury or more diffuse as in disorders or diseases.Compression fractures of the vertebrae are common in advanced age (such as in this patient) and are treated with rest, medications, braces, or possibly surgery.The administration of opioids for analgesic purposes is not considered a medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure, however, the incident was potentially life-threatening and resulted in a fracture of the patient¿s lumbar vertebrae, indicating a serious injury occurred.Although there was no malfunction found and the incident was determined to be caused by use error, if the report of a detachment of the hook resulting in a patient fall were to recur, it might lead to the outcome of a serious incident such as death or an unanticipated serious deterioration in a person's state of health.

• 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 975 9 2; SW 975 92
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 20614700
• Report Number: 8030916-2024-00094
• Device Sequence Number: 8906070
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 11/05/2024

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: 2010004
• Device Catalogue Number: 2010004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2024
• Initial Report FDA Received Date: 11/05/2024
• 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: Other
• Patient Sex: Male
• Patient Weight: 64 KG