BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAREASSIST BED

    MDR report key: 23812701 · Received December 15, 2025

    Report

    Report Number
    3006697241-2025-00338
    Event Type
    Malfunction
    Date Received
    December 15, 2025
    Date of Event
    December 9, 2025
    Report Date
    December 15, 2025
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FNL
    UDI-DI
    00887761000278
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE BAXTER TECHNICIAN FOUND THE LEFT SIDERAIL NEEDED TO BE RECONNECTED. 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 JUN 30, 2025. IT IS UNKNOWN IF THE FACILITY PERFORMED ANY OTHER PREVENTATIVE MAINTENANCE ON THIS BED. THE TECHNICIAN RECONNECTED THE LEFT SIDERAIL TO RESOLVE THE REPORTED EVENT. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 0

    ON 09-DEC-2025, A COMPANY REPRESENTATIVE - SERVICE PERSONNEL CONTACTED TECHNICAL SERVICE TO REPORT THAT CARE ASSIST ES155/255/455, NUL (PRODUCT CODE P1170G0000040, SERIAL NUMBER (B)(6), HAD A LEFT SIDERAIL FALSE LATCHING. 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
    2205595 CAREASSIST BED BED, AC-POWERED ADJUSTABLE HOSPITAL FNL BAXTER HEALTHCARE CORPORATION P1170G 00887761000278

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown