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

Model Number	3121001
Medical Device Problem Codes	Break (1069); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Fall (1848)
Date of Event	02/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.¿ an inspection of the device by a baxter service technician is pending.An onsite visit by a baxter lift representative noted that the facility was using the likorall device with a sling/harness (nausicaa) that was not compatible with the likorall device.An examination of the images provided by the customer found that the slingbar¿s quick-release red catch hook was broken and images display that the catch was likely broken prior to this event.The device instructions for use states the following when using a device fitted with a quick release hook ¿push down the red catch and connect the quick-release hook to the q-link.Release and check that the catch locks in order to prevent involuntary unhooking from the q-link.Before lifting check that the quick-release hook is correctly attached to q-link.¿ the device also provides an illustration of the correct placement/attachment of the hook.In this event, the patient experienced back and buttock pain with no further injury following a fall from approximately 1.20 meters.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.Although a device inspection is pending, it is noted that the customer attributes the cause of the event to use error.If the reported use error event (using incompatible sling and/or device with broken equipment) were to recur, it would be likely to cause or contribute to a death or serious injury.A final report will be submitted upon completion of the investigation.
Event or Problem Description
Baxter was made aware of an event involving a likorall 200 device.The customer reported that while a patient was being transferred, the ¿support at the end of the rail broke¿ (red safety catch), and the patient fell to the ground approximately 1.20 meters.The patient was reported to have pain in the back and buttocks following the event.There were no wounds and no bleeding.The patient was taken to the hospital, provided level 2 pain medication, and returned to the facility the same day.
Additional Manufacturer Narrative
It was reported that the customer refused the repair intervention.The customer replaced the slingbar themselves since the red locking part on the slingbar's quick-release hook was damaged.A baxter representative was able to witness a transfer from the chair to the bed of a resident.It was observed that the customer used the multirall together with a non-liko sling the baxter representative provided information for use with caregivers including the below instructions.Harnesses must be well centered when positioned on residents' backs.Only use compatible accessories with the liko patient lift.The baxter technician recommended appropriate harnesses to use in conjunction with the lift.The following assembly instructions are outlined in the likorall 200 ifu: before lifting check that the quick-release hook is correctly attached to the q-link.The cause of the event was determined to be due to use error.If the reported use error event (using incompatible sling and/or device with broken equipment) were to recur, it would be likely to cause or contribute to a death or serious injury.
Event or Problem Description
Baxter was made aware of an event involving a likorall 200 device.The customer reported that while a patient was being transferred, the ¿support at the end of the rail broke¿ (red safety catch), and the patient fell to the ground approximately 1.20 meters.The patient was reported to have pain in the back and buttocks following the event.There were no wounds and no bleeding.The patient was taken to the hospital, provided level 2 pain medication, and returned to the facility the same day.

• 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 97592 ; SW 97592
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 22292699
• Report Number: 8030916-2025-00081
• Device Sequence Number: 20898802
• Product Code: FSA
• UDI-Device Identifier: 00887761981911
• UDI-Public: (01)00887761981911
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2025

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: 05/27/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2025
• Supplement Date Received by Manufacturer: 08/26/2025
• Initial Report FDA Received Date: 06/19/2025
• Supplement Report FDA Received Date: 09/18/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: N/A.; N/A.
• Patient Sex: Unknown