MAUDE Adverse Event Report: LIKO AB LIKO SOLO HIGHBACK SLING, MOD. 25; LIFT, PATIENT, NON-AC-POWERED

Model Number	3525915
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/19/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Patient was being lifted from the bed to the chair with the ceiling lift and green sling.While the patient was in the air, there was loud popping coming from the sling.The patient was immediately lowered, and the sling was removed.Some stitches in the fabric appeared to be broken.The sling used was rated for up to 440lb.No patient harm, no damage to lift equipment.Grabbed new sling and it worked as expected.Manufacturer response for sling, solo highback sling (per site reporter).This was reported to the vendor on friday, 10/20/2023.On monday 10/23/2023 the po # that the sling was purchased was sent to the vendor along with a request that they send a call tag for the review of the product.The vendor has not replied back.The vendor was emailed again today 10/26/2023 and they have not yet replied back.

• Brand Name: LIKO SOLO HIGHBACK SLING, MOD. 25
• Common Device Name: LIFT, PATIENT, NON-AC-POWERED
• Manufacturer (Section D): LIKO AB; 25212 w. il route 120; rlt-10; round lake IL 60073
• MDR Report Key: 18855875
• Report Number: 18855875
• Device Sequence Number: 3338548
• Product Code: FSA
• UDI-Device Identifier: 00887761983403
• UDI-Public: (01)00887761983403
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/26/2023
• Report Date (Section F): 10/26/2023

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: Health Professional
• Device Model Number: 3525915
• Device Catalogue Number: 3525915
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/07/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/07/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Weight: 140 KG
• Date Report Sent to FDA: 10/26/2023