BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SABINA II EE

    MDR report key: 20980418 · Received December 19, 2024

    Report

    Report Number
    8030916-2024-00121
    Event Type
    Malfunction
    Date Received
    December 19, 2024
    Date of Event
    November 25, 2024
    Report Date
    December 19, 2024
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE BAXTER TECHNICIAN REPLACED THE CONTROL BOX KIT TO RESOLVE THE ISSUE. 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 ELECTRICAL PARTS OF BAXTERS LIFTS ARE COMPLIANT WITH IEC 60601-1 (MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE) WHICH APPLIES TO THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF MEDICAL ELECTRIC EQUIPMENT AND MEDICAL ELECTRIC SYSTEMS. EVEN AS BAXTERS LIFTS COMPLY TO THE ABOVE MENTIONED ELECTRICAL STANDARD, THERE IS STILL A RISK THAT ABNORMAL WEAR AND TEAR CAN DAMAGE THE CABLES. THEREFORE, IN THE PERIODIC INSPECTION MANUAL FOR LIKO MOBILE LIFTS (3EN371001 REV. 5) IT IS STATED UNDER SECTION 8: CHECK CABLES AND CONNECTORS FOR DAMAGE OR WEAR. ALTHOUGH THE REPORTED EVENT DID NOT RESULT IN A SERIOUS INJURY, IF THE DEVICES CONTROL BOX WERE TO OVERHEAT AND BURN OUT DURING USE, IT COULD CONTRIBUTE TO A SERIOUS INJURY OR DEATH, IF THE MALFUNCTION WERE TO RECUR. THEREFORE, BAXTER CONSIDERS THIS COMPLAINT A REPORTABLE MALFUNCTION.

    Description of Event or Problem · 0

    A COMPANY REPRESENTATIVE CONTACTED TECHNICAL SERVICE TO REPORT THAT THE SABINA II EE CONTROL BOX HAD BURNT OUT. 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
    2115526 SABINA II EE LIFT PATIENT NON AC POWERED FSA BAXTER HEALTHCARE CORPORATION 2020003 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown