BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTRELLA BED

    MDR report key: 23063172 · Received September 16, 2025

    Report

    Report Number
    1824206-2025-01597
    Event Type
    Malfunction
    Date Received
    September 16, 2025
    Date of Event
    August 26, 2025
    Report Date
    September 16, 2025
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FNL
    UDI-DI
    00887761985162
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE BAXTER TECHNICIAN FOUND THE RIGHT HFB AND CONTROL PANEL NEEDED TO BE REPLACED AND SOFTWARE NEEDED TO BE UPDATED. 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 DID NOT SHOW BAXTER PERFORMED ANY PREVENTATIVE MAINTENANCE ON THIS BED. IT IS UNKNOWN IF THE FACILITY PERFORMS PREVENTATIVE MAINTENANCE ON THEIR BEDS. THE TECHNICIAN REPLACED THE RIGHT HFB, CONTROL PANEL, AND UPDATED SOFTWARE TO RESOLVE THE REPORTED EVENT. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 0

    BAXTER RECEIVED A REPORT FROM A BAXTER TECHNICIAN TO REPORT THE CENTRELLA MED-SURG BED WAS MOVING ON ITS OWN. THE BED WAS LOCATED AT THE ACCOUNT. THE PROCESS STEP DURING WHICH THIS OCCURRED WAS UNKNOWN. THERE WAS NO PATIENT/USER INJURY, MEDICAL INTERVENTION, SYMPTOM, OR ADVERSE EVENT REPORTED. THERE WERE NO OTHER DEVICES REPORTED TO BE INVOLVED. THE CUSTOMER DID NOT COMMUNICATE THIS EVENT TO ANOTHER BAXTER DEPARTMENT OR AUTHORITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2651173 CENTRELLA BED BED, AC-POWERED ADJUSTABLE HOSPITAL FNL BAXTER HEALTHCARE CORPORATION P7900B NI 00887761985162

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown