BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GOLVO 8000

    MDR report key: 22675700 · Received July 31, 2025

    Report

    Report Number
    8030916-2025-00094
    Event Type
    Malfunction
    Date Received
    July 31, 2025
    Date of Event
    July 2, 2025
    Report Date
    December 31, 2025
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FSA
    UDI-DI
    00887761981751
    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 EVALUATION 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.

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2025 THE CUSTOMER REPORTED THAT A PATIENT WAS INJURED WHILE THE GOLVO 8008 LIFT WAS BEING USED. THE REPORTER INITIALLY STATED THEY WERE UNSURE IF THE STAFF WAS RESPONSIBLE FOR THE EVENT OR IF THE LIFT MALFUNCTIONED. DURING FOLLOW-UP, THE REPORTER STATED THAT THE EVENT ¿WAS NOT A RESULT OF THE EQUIPMENT¿, HOWEVER, DESPITE MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION, NO DETAILS OF THE REPORTED PATIENT INJURY WAS PROVIDED. THE GOLVO MOBILE LIFT IN INTENDED TO BE USED FOR TRANSFERRING PATIENTS (ADULT OR CHILDREN) BETWEEN DEVICES (E.G., WITHIN THE ROOM), FLOOR LIFTING, HORIZONTAL LIFTING, SUPPORTING PATIENT LIMBS, AMBULATING PATIENT, BATHING PATIENT, TOILETING PATIENT, WEIGHING PATIENT AND TRANSFERRING PATIENTS FROM CAR. INTENDED FOR USE IN FOLLOWING ENVIRONMENTS: HEALTH CARE, INTENSIVE CARE, EMERGENCY WARD, REHABILITATION, HABILITATION. IN THIS EVENT, THE CUSTOMER DID NOT PROVIDE THE NECESSARY INFORMATION TO DETERMINE THE SEVERITY OF THE REPORTED EVENT. THERE WAS NO INDICATION THAT THE REPORTED ADVERSE EVENT WAS SERIOUS IN NATURE, AND THERE WAS NO REPORT OF REQUIRED MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE. THEREFORE, THIS EVENT WILL BE ASSESSED AS NON-SERIOUS. DUE TO THE SPARSITY OF THE INFORMATION PROVIDED, THE EXACT CAUSE CANNOT BE DETERMINED AT THIS TIME, HOWEVER, BASED ON THE CUSTOMER REPORT THAT THE EVENT ¿WAS NOT A RESULT OF THE EQUIPMENT¿, IT IS REASONABLE TO CONCLUDE THAT THE EVENT WAS UNLIKELY CAUSED OR CONTRIBUTABLE TO THE USE OF THE DEVICE. THE SERVICE TECHNICIAN INSPECTED THE LIFT AND FUND THAT THE BATTERY WAS UNABLE TO CHARGE DUE TO A FAILED CONTROL BOX. THE CONTROL BOX DID NOT CHARGE THE BATTERY AND NEEDED TO BE REPLACED TO RESOLVE THE ALLEGED ISSUE. THE TECHNICIAN RECEIVED INFORMATION FROM THE CUSTOMER THAT THE REPORTED INJURY WAS DUE TO USER ERROR. THE ONLY ISSUE THE TECHNICIAN FOUND WITH THE LIFT WAS THE CONTROL BOX, WHICH NEEDED TO BE REPLACED DUE TO NO CHARGING LIGHT. THE TECHNICIAN REPLACED THE BATTERY TO RESOLVE THE REPORTED EVENT. IF ANY FURTHER, RELEVANT INFORMATION IS RECEIVED, THE RECORD WILL BE REASSESSED ACCORDINGLY.

    Description of Event or Problem · 0

    ON 02-JUL-2025 THE CUSTOMER REPORTED THAT A PATIENT WAS INJURED WHILE THE GOLVO 8008 LOWBASE (PRODUCT CODE 2000039, SERIAL NUMBER (B)(6), LIFT WAS BEING USED. THE REPORTER INITIALLY STATED THEY WERE UNSURE IF THE STAFF WAS RESPONSIBLE FOR THE EVENT OR IF THE LIFT MALFUNCTIONED. DURING FOLLOW-UP, THE REPORTER STATED THAT THE EVENT ¿WAS NOT A RESULT OF THE EQUIPMENT¿. THERE WAS NO INDICATION THAT THE REPORTED ADVERSE EVENT WAS SERIOUS IN NATURE, AND THERE WAS NO REPORT OF REQUIRED MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2277887 GOLVO 8000 LIFT, PATIENT, NON-AC-POWERED FSA BAXTER HEALTHCARE CORPORATION 2000039 00887761981751

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown