MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION SABINA II EE; LIFT, PATIENT, NON-AC-POWERED

Model Number	2020003
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation into the reported event is currently on going.A final report will be submitted upon completion of the investigation.
Event or Problem Description
A distributor contacted technical service to report that the sabina ii ee had an issue, the slingbar (b)(6) was unused from stock and out of the box.The customer noticed there were loose screws on the slingbar.It was reported the loose screws were not obvious because they are assembled to the bottom side of tube.This occurred during patient use.There was no patient/user injury, medical intervention, symptom, or adverse event reported.
Additional Manufacturer Narrative
The baxter technician found the screw to the left hook was not tightened enough and sling bar needed to be replaced.The sabina sit-to-stand lift is especially designed for people who have difficulty in standing up on their own from a seated position.Sabina sit-to-stand lift is intended for use with patients who are able to actively participate in the raising motion.When standing, they can be moved to a wheelchair or to a toilet, this gives them standing practice in connection with the transfer.A search of the baxter maintenance records did not show baxter performed any preventative maintenance on this device.It is unknown if the facility performs preventative maintenance on their device.The technician replaced the sling bar to resolve the reported event.Based on this information, no further action is required.

• Brand Name: SABINA II EE
• 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, norrbottens lan [se-25] 975 9 2; SW 975 92
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 23830315
• Report Number: 8030916-2025-00146
• Device Sequence Number: 17391567
• Product Code: FSA
• UDI-Device Identifier: 00887761981782
• UDI-Public: (01)00887761981782(11)241209
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: NA
• 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): 02/20/2026

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: 2020003
• Device Catalogue Number: 2020003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2025
• Supplement Date Received by Manufacturer: 02/18/2026
• Initial Report FDA Received Date: 12/17/2025
• Supplement Report FDA Received Date: 02/20/2026
• 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: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: N/A.
• Patient Sex: Unknown