BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSACARE MED SURG BED

    MDR report key: 24845741 · Received April 10, 2026

    Report

    Report Number
    1824206-2026-00827
    Event Type
    Malfunction
    Date Received
    April 10, 2026
    Date of Event
    March 17, 2026
    Report Date
    April 10, 2026
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FNL
    UDI-DI
    00887761000872
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE BAXTER TECHNICIAN FOUND THE HAND PENDANT NEEDED TO BE REPLACED. PER THE BAXTER SERVICE MANUAL, IT IS NECESSARY FOR THE CENTRELLA BED TO HAVE AN EFFECTIVE MAINTENANCE PROGRAM. WE RECOMMEND THAT YOU DO ANNUAL PREVENTIVE MAINTENANCE. DO THE FUNCTION CHECKS AS APPLICABLE FOR YOUR BED. IF THE BED PASSES ALL OF THE CHECKS FOR ITS CONFIGURATION, DO THE NECESSARY ADMINISTRATIVE TASKS, AND PREPARE THE BED TO BE PUT INTO SERVICE. IF THE BED DOES NOT PASS ALL OF THE CHECKS, REPAIR OR REPLACE THE PART AS APPLICABLE. DO NOT PUT THE BED INTO SERVICE UNTIL IT PASSES ALL OF THE CHECKS. WARNING¿REPORT TO BED AUTHORIZED MAINTENANCE PERSONS ANY UNUSUAL SOUNDS, BURNING ODORS, OR MOVEMENT DEVIATIONS OBSERVED IN THE CONTROLS, MOTORS, OR LIMIT SWITCH FUNCTIONS. CHECK THE CABLE CONNECTION BETWEEN THE MCB AND BCB. REPLACE OR CONNECT THE CABLE AS NECESSARY. REPLACE THE BCB. A SEARCH OF THE BAXTER MAINTENANCE RECORDS SHOWED BAXTER PERFORMED PREVENTATIVE MAINTENANCE ON THIS BED IN FEB 5, 2026. IT IS UNKNOWN IF THE FACILITY PERFORMED ANY OTHER PREVENTATIVE MAINTENANCE ON THIS BED. THE TECHNICIAN REPLACED THE HAND PENDANT TO RESOLVE THE REPORTED EVENT. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 0

    BAXTER RECEIVED A REPORT THAT VERSACARE FRAME HAD HEAD RAISING AUTOMATICALLY WITHOUT ANY BUTTONS BEING PRESSED. 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
    899591 VERSACARE MED SURG BED BED, AC-POWERED ADJUSTABLE HOSPITAL FNL BAXTER HEALTHCARE CORPORATION P3200K 00887761000872

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown