MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION LIKORALL 243 ES; LIFT PATIENT NON AC POWERED

Model Number	3123001
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Fall (1848); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
During follow up with the customer it was determined that the q link had not been properly attached during a transfer resulting in the patient falling onto the bed.The caregiver reportedly caught the qlink.It was additionally noted that the q link had acquired damage to the lock indicating that it wasnt hooked up correctly causing distortion to the red safety lock.It was also reported that there was deformation of the slingbar joint indicating the slingbar was violently twisted.The qrh and slingbar was replaced for the customer to resolve the issue.The universal slingbar can be used in combination with liko slings that attaches to the sling bar using sling loops.Liko universal sling bars are with two assembly options, fixed assembly or with quick-release hook.The liko universal sling bars instructions for use (7en160185 rev.5) states the following under care and maintenance: 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.Although there was no patient injury reported and the incident was likely caused by incorrect attachment of the quick release hook, if the incident were to recur it would could cause serious injury or death.Therefore, baxter is reporting this use error.
Event or Problem Description
Baxter received a user report from the danish medicines agency reporting the following incident: the harness was not tightened properly during patient use.There was no patient injury reported.

• Brand Name: LIKORALL 243 ES
• 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: 20725553
• Report Number: 8030916-2024-00102
• Device Sequence Number: 20957165
• Product Code: FSA
• UDI-Device Identifier: 00887761979529
• UDI-Public: (01)00887761979529
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 11/19/2024

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: 3123001
• Device Catalogue Number: 3123001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2024
• Initial Report FDA Received Date: 11/19/2024
• 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
• Patient Sex: Unknown