MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION LIKORALL 200; LIFT PATIENT NON AC POWERED

Model Number	3121001
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Pain (1994)
Date of Event	02/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that during the use of the likorall 200, the device¿s lift strap dropped down approximately 30cm while lifting the patient.The customer reported that there was no injury with the event, however, the patient did report experiencing ¿lower back pain¿ as a result.There was no report of medical intervention for the reported pain.The likorall overhead lift is intended for use in lifting and transferring patients, for example, from bed to a wheelchair, to or from the floor, for visits to the toilet, for gait, standing, and balance training, when weighing the patient, and when lifting the patient with a stretcher.The device instructions for use state ¿before lifting always ensure that: the lift strap is not twisted or worn and can move in and out of the lift unit freely; the lifting accessories are not damaged; the sling is correctly and securely applied to the patient in order to prevent injuries from occurring; and the lifting accessory is correctly applied to the lift.¿.
Additional Manufacturer Narrative
An inspection of the device performed by a baxter service technician confirmed a breakage of the device¿s shaft.Additionally, a functional test of the device¿s single fault safety system showed the safety system did not function as intended, noting that the oil level in the safety system¿s drum was below specifications, although no leak was detected.The failure of the safety system is attributed to the incorrect level of fluid.In this event, the patient reportedly experienced back pain.Pain is an unpleasant sensation that typically stops once the stimulus is removed, is not life-threatening, and does not require medical or surgical intervention to preclude permanent impairment of a body function or body structure.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, which concludes that no serious injury occurred.The cause of the event is attributed to the breakage of the device¿s shaft, and subsequent failure of the device¿s single-fault safety system to engage at the time of the event.If the reported malfunctions were to recur, it is likely to result in serious injury or death.

• Brand Name: LIKORALL 200
• 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: 22563201
• Report Number: 8030916-2025-00090
• Device Sequence Number: 9348019
• Product Code: FSA
• UDI-Device Identifier: 00887761981911
• UDI-Public: (01)00887761981911
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/22/2025

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
• Device Model Number: 3121001
• Device Catalogue Number: 3121001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2025
• Initial Report FDA Received Date: 07/22/2025
• 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