BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SABINA MOBILE LIFT

    MDR report key: 24571560 · Received March 11, 2026

    Report

    Report Number
    8030916-2026-00026
    Event Type
    Malfunction
    Date Received
    March 11, 2026
    Date of Event
    February 13, 2026
    Report Date
    May 20, 2026
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FSA
    UDI-DI
    00887761981782
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    NO FURTHER INFORMATION IS AVAILABLE ON THE REPAIR OF THE DEVICE AT THIS TIME. THE INVESTIGATION IS ONGOING, HOWEVER IF ANY ADDITIONAL RELEVANT INFORMATION IS IDENTIFIED FOLLOWING THE COMPLETION OF THE INVESTIGATION, THE ADDITIONAL RELEVANT INFORMATION IS IDENTIFIED FOLLOWING COMPLETION OF THE INVESTIGATION, THE ADDITIONAL RELEVANT INFORMATION WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. 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.

    Additional Manufacturer Narrative · 0

    THE BAXTER TECHNICIAN FOUND THE MAST WELDMENT NEEDED TO BE REPLACED. 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 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. THE TECHNICIAN REPLACED THE MAST WELDMENT TO RESOLVE THE REPORTED EVENT. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED. ALTHOUGH THERE WAS NO REPORTED INJURY WITH THIS EVENT, IF THE REPORT OF A CRACKED MAST WERE TO RECUR, IT COULD POTENTIALLY CAUSE SERIOUS INJURY OR DEATH. THEREFORE, BAXTER IS REPORTING THIS EVENT.

    Description of Event or Problem · 0

    ON 13-FEB-2026, A COMPANY REPRESENTATIVE - SERVICE PERSONNEL CONTACTED TECHNICAL SERVICE TO REPORT THAT SABINA II EE BASIC (PRODUCT CODE P2020003, SERIAL NUMBER (B)(6)), HAD MAST WELDMENT CRACKED. THE PROCESS STEP DURING WHICH THIS OCCURRED WAS UNKNOWN. THERE WAS NO PATIENT/USER INJURY, MEDICAL INTERVENTION, SYMPTOM, OR ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    476296 SABINA MOBILE LIFT LIFT, PATIENT, NON-AC-POWERED FSA BAXTER HEALTHCARE CORPORATION P2020003 00887761981782

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown N/A.