MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION LIKORALL 242 S, NATURAL; LIFT PATIENT NON AC POWERED

Model Number	P3122009
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information regarding the reported event has been requested and a device inspection is still pending.Although the sequence of events leading to the reported issue are currently unknown, if a slingbar were to become disengaged from the lift during a patient transfer, it could lead to serious injury or death.All relevant additional information received throughout the course of the investigation will be submitted in a supplemental report.
Event or Problem Description
A company representative - service personnel contacted technical service to report that the likorall 242 s, natural, had an issue, customer stated the sling bar is disengaged from the strap.The process step during which this occurred was unknown.There was no patient/user injury, medical intervention, symptom, or adverse event reported.There were no other devices reported to be involved.The device was requested for service/inspection by baxter.
Additional Manufacturer Narrative
The service technician inspected the lift and checked its functions.The technician discovered that the slingbar's quick disconnect hook (quick-release hook) was broken and needed to be replaced.The issue was resolved by replacing the quick-release hook.The lift in this complaint was shipped in 2012 and is therefore beyond its expected life time of 10 years.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.Although there was no adverse event reported, if the slingbar were to become disengaged from the lift during a patient transfer, it could lead to serious injury or death.
Event or Problem Description
A company representative - service personnel contacted technical service to report that the likorall 242 s, natural, had an issue, customer stated the sling bar is disengaged from the strap.The process step during which this occurred was unknown.There was no patient/user injury, medical intervention, symptom, or adverse event reported.There were no other devices reported to be involved.The device was requested for service/inspection by baxter.

• Brand Name: LIKORALL 242 S, NATURAL
• 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: 21629785
• Report Number: 8030916-2025-00050
• Device Sequence Number: 21064194
• Product Code: FSA
• UDI-Device Identifier: 00887761979796
• UDI-Public: (01)00887761979796
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Followup
• Report Date (Section B): 09/04/2025

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: P3122009
• Device Catalogue Number: P3122009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2025
• Supplement Date Received by Manufacturer: 08/12/2025
• Initial Report FDA Received Date: 03/18/2025
• Supplement Report FDA Received Date: 09/04/2025
• 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