BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAREASSIST BED

    MDR report key: 22115415 · Received May 30, 2025

    Report

    Report Number
    3006697241-2025-00172
    Event Type
    Malfunction
    Date Received
    May 30, 2025
    Date of Event
    May 6, 2025
    Report Date
    May 30, 2025
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FNL
    UDI-DI
    00887761000278
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE BAXTER TECHNICIAN FOUND THE COMMUNICATION CABLE NEEDED TO BE REPLACED. PER THE 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. EVERY FIVE YEARS, THE BED EXIT TAPE SWITCHES SHOULD BE REPLACED BY A FACILITY-AUTHORIZED MAINTENANCE PERSONNEL. ENSURE THE BED EXIT SYSTEM WORKS PROPERLY. REPLACE WORN OR DEFECTIVE PARTS AS NEEDED. A SEARCH OF THE BAXTER MAINTENANCE RECORDS SHOWED BAXTER PERFORMED PREVENTATIVE MAINTENANCE ON THIS BED IN MAR 9, 2023. IT IS UNKNOWN IF THE FACILITY PERFORMED ANY OTHER PREVENTATIVE MAINTENANCE ON THIS BED. THE TECHNICIAN REPLACED THE COMMUNICATION CABLE TO RESOLVE THE REPORTED EVENT. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 0

    DURING SERVICING BY BAXTER, TECHNICAL SERVICE IDENTIFIED THAT CAREASSIST ES155/255/455, NUL (PRODUCT CODE P1170G0000040, SERIAL NUMBER (B)(6)), HAD BED EXIT ALARM NOT SENDING PRIORITY CALL TO NURSE'S STATION. THIS OCCURRED DURING BAXTER SERVICING/TESTING. THERE WAS NO PATIENT/USER INJURY, MEDICAL INTERVENTION, SYMPTOM, OR ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    845099 CAREASSIST BED BED, AC-POWERED ADJUSTABLE HOSPITAL FNL BAXTER HEALTHCARE CORPORATION P1170G 00887761000278

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown