BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAREASSIST BED

    MDR report key: 24089831 · Received January 15, 2026

    Report

    Report Number
    3006697241-2026-00025
    Event Type
    Malfunction
    Date Received
    January 15, 2026
    Date of Event
    December 21, 2025
    Report Date
    January 15, 2026
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FNL
    UDI-DI
    887761000278
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE BAXTER TECHNICIAN FOUND THE CASTERS AND WHEEL SUPPORTS NEEDED TO BE REPLACED. PER THE BAXTER SERVICE MANUAL THE BED SHOULD BE SUBJECT TO AN EFFECTIVE MAINTENANCE PROGRAM. AN ANNUAL SERVICE OF THE BED IS ADVISED IN ORDER TO MAINTAIN ITS CHARACTERISTICS AND PERFORMANCE. BRAKE CASTERS SHOULD BE CHECKED FOR CUTS, WEAR AND QUALITY OF TREAD, ETC. AND REPLACED WHEN NECESSARY. CHECK THE BRAKES TO SEE WHETHER THE BED MOVES WHEN THE BRAKE PEDALS ARE PRESSED AND REPAIR AS NECESSARY. A SEARCH OF THE BAXTER MAINTENANCE RECORDS SHOWED BAXTER PERFORMED PREVENTIVE MAINTENANCE ON THIS BED ON SEP 28, 2023. IT IS UNKNOWN IF THE FACILITY PERFORMED ANY OTHER PREVENTIVE MAINTENANCE ON THIS BED. THE TECHNICIAN REPLACED THE CASTERS AND WHEEL SUPPORTS TO RESOLVE THE REPORTED EVENT. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 0

    ON 21-DEC-2025, A COMPANY REPRESENTATIVE - SERVICE PERSONNEL CONTACTED TECHNICAL SERVICE TO REPORT THAT CAREASSIST ES155/255/455, NUL (PRODUCT CODE: P1170G0000040, SERIAL NUMBER: (B)(6), HAD BRAKES NOT HOLDING. THIS OCCURRED DURING PATIENT USE. THERE WAS NO PATIENT/USER INJURY, MEDICAL INTERVENTION, SYMPTOM, OR ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148458 CAREASSIST BED BED, AC-POWERED ADJUSTABLE HOSPITAL FNL BAXTER HEALTHCARE CORPORATION P1170G N/A 887761000278

    Patients

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