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

Model Number	2020003
Medical Device Problem Codes	Use of Incorrect Control/Treatment Settings (1126); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	06/05/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a patient suffered a dislocated shoulder with a sabina mobile lift.Reportedly, the caregiver ¿was not using the sling correctly¿ and the patient sustained a dislocated shoulder (no further information on testing or medical information were provided).No further information was available at the time of this report.
Additional Manufacturer Narrative
H11: the device was evaluated onsite by a qualified technician.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.The device underwent functional testing, and the sling performed according to product specifications.A service history review was performed and revealed that the device has no previous service events; therefore, servicing did not cause or contribute to the reported event.Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
Investigation indicated that there was no evidence of a malfunction or product issue.Baxter was unable to duplicate the alleged condition and the device performed as designed.The customer could not tell the technician how the event happened.The safety reviewer received information from the customer that the event was contributed to user error as "staff was not using the sling properly".However, the customer did not elaborate further on this statement.Based on the information that has been provided, it is reasonable to conclude that the event was caused by user error (sling incorrectly applied to sling bar by caregiver/staff).Since the event resulted in a serious injury and was determined to be caused by user error, the customer was contacted to be offered training on how to use the medical device.The associate account executive made several attempts to contact the customer regarding the proposed training, but the customer did not supply any dates or times to conduct the training.Therefore, customer training could not be performed.This statement is available in the sabina ii instructions for use (7en155106 rev.3) under safety information on page 3: before lifting, always make sure that: the lifting accessories are not damaged.The lifting accessory is selected appropriately in terms of type, size, material, and design with regard to the patient¿s needs.The lifting accessory is correctly and safely applied to the patient in order to prevent injuries.The lifting accessory is correctly applied to the sling bar.The sling bar latches are intact; missing or damaged latches must always be replaced with new ones.The sit-to-stand vest¿s/sling¿s straps are correctly connected to the sling bar hooks when the straps are stretched up but before the patient is lifted from the underlying surface.As a caregiver make sure that the patient is not at risk of falling forward or to any side during lifting.

• Brand Name: SABINA MOBILE LIFT
• 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: 22383719
• Report Number: 8030916-2025-00085
• Device Sequence Number: 15657990
• Product Code: FSA
• UDI-Device Identifier: 00887761981782
• UDI-Public: (01)00887761981782
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Other
• Device Model Number: 2020003
• Device Catalogue Number: SABINAEE/2EE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2025
• Supplement Date Received by Manufacturer: 03/26/2026
• Initial Report FDA Received Date: 07/02/2025
• Supplement Report FDA Received Date: 04/21/2026
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown