MAUDE Adverse Event Report: LIKO AB COMFORTSLING PLUS 300 MESH L; LIFT, PATIENT, NON-AC-POWERED

Model Number	3121001
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A baxter technician inspected the sling and confirmed that the harness was torn but was unable to determine what caused the tear.Per the customer, the incident occurred during a patient transfer and when the strap was put under tension, it broke.It was additionally confirmed that there was no patient fall or injury as a result.The customer was sent a replacement sling.Liko comfortsling plus provides a comfortable sitting position and adapts to suit the patient and no individual adjustments are required.Comfortsling plus provides the patient with good back and head support (mod.350).Comfortsling plus is gentle to apply since the patient is in a supine position during the application and the sling remains in the chair after the transfer.Comfortsling plus is suitable for patients who are especially sensitive due to muscle or joint pain.The instructions for use for comfort sling plus 350 ((b)(4) rev # 8) states under care and maintenance: "inspect the sling before each use.Inspect the following points with regard to wear and damage: ¿ fabric ¿ straps ¿ seams ¿ loops do not use damaged lifting accessories." although there was no injury reported, if the sling were to tear during patient use it could lead to a serious injury or death therefore, baxter is reporting this event.
Event or Problem Description
The customer alleged the lift¿s harness was torn.There was no patient involvement reported.This report was filed in our complaint handling system as (b)(4).

• Brand Name: COMFORTSLING PLUS 300 MESH L
• Common Device Name: LIFT, PATIENT, NON-AC-POWERED
• Manufacturer (Section D): LIKO AB; nedre vagen 100; lulea, norrbottens lan [se-25] 975 9 2; SW 975 92
• Manufacturer Contact: keighley crosthwaite ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 19153638
• Report Number: 8030916-2024-00018
• Device Sequence Number: 8446016
• Product Code: FSA
• UDI-Device Identifier: 00887761981911
• UDI-Public: 010088776198191111220226
• 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,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/22/2024

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
• Device Model Number: 3121001
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2024
• Initial Report FDA Received Date: 04/22/2024
• 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