BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAREASSIST BED

    MDR report key: 24135648 · Received January 21, 2026

    Report

    Report Number
    3006697241-2026-00033
    Event Type
    Malfunction
    Date Received
    January 21, 2026
    Date of Event
    December 27, 2025
    Report Date
    January 21, 2026
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FNL
    UDI-DI
    00887761000278
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE BAXTER TECHNICIAN FOUND THE HEAD END SIDERAIL CABLES 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. MAKE SURE THE HEAD AND FOOT SIDERAILS ARE NOT BENT OR TWISTED. MAKE SURE THE LATCH MECHANISM OPERATES CORRECTLY. AN AUDIBLE CLICK MUST BE HEARD. REMOVE THE SIDERAIL COVER, AND MAKE SURE THE MOUNTING SCREWS ARE TIGHT. REPAIR OR REPLACE THE SIDERAIL AS NECESSARY. A SEARCH OF THE BAXTER MAINTENANCE RECORDS SHOWED BAXTER PERFORMED PREVENTATIVE MAINTENANCE ON THIS BED IN JAN 17, 2025. IT IS UNKNOWN IF THE FACILITY PERFORMED ANY OTHER PREVENTATIVE MAINTENANCE ON THIS BED. THE TECHNICIAN REPLACED THE HEAD END SIDERAIL CABLES TO RESOLVE THE REPORTED EVENT. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 0

    ON 27-DEC-2025, A COMPANY REPRESENTATIVE - SERVICE PERSONNEL CONTACTED TECHNICAL SERVICE TO REPORT THAT CAREASSIST ES155/255/455, NUL (PRODUCT CODE P1170GHPG0001, SERIAL NUMBER (B)(6)), HAD MULTIPLE ARTICULATION SELF RUN. THERE WAS NO PATIENT/USER INJURY, MEDICAL INTERVENTION, SYMPTOM, OR ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    198760 CAREASSIST BED BED, AC-POWERED ADJUSTABLE HOSPITAL FNL BAXTER HEALTHCARE CORPORATION P1170GH 00887761000278

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown