BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAREASSIST BED

    MDR report key: 21979049 · Received May 7, 2025

    Report

    Report Number
    3006697241-2025-00143
    Event Type
    Malfunction
    Date Received
    May 7, 2025
    Date of Event
    April 21, 2025
    Report Date
    May 7, 2025
    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 PATIENT LEFT SIDERAIL CABLE ASSEMBLY WAS CUT AND 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. INSPECT THE CABLE ROUTING FOR PINCHING, BINDING, AND DAMAGE. MAKE SURE ALL FUNCTIONS ON THE CAREGIVER CONTROL OPERATE CORRECTLY. A SEARCH OF THE BAXTER MAINTENANCE RECORDS SHOWED BAXTER PERFORMED PREVENTATIVE MAINTENANCE ON THIS BED IN JUL 17, 2024. IT IS UNKNOWN IF THE FACILITY PERFORMED ANY OTHER PREVENTATIVE MAINTENANCE ON THIS BED. THE TECHNICIAN REPLACED THE SIDERAIL CABLE TO RESOLVE THE REPORTED EVENT. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT CAREASSIST ES155/255/455, NUL (PRODUCT CODE P1170GHPG0001, SERIAL NUMBER (B)(6)), HAD BED ARTICULATION SELF RUNS. THIS OCCURRED AFTER PATIENT USE. THERE WAS NO PATIENT/USER INJURY, MEDICAL INTERVENTION, SYMPTOM, OR ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    423097 CAREASSIST BED BED, AC-POWERED ADJUSTABLE HOSPITAL FNL BAXTER HEALTHCARE CORPORATION P1170G 00887761000278

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown