BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HILLROM BAXTER CENTRELLA BEDS WITH PRO+ MATTRESSES

    MDR report key: 19428656 · Received May 29, 2024

    Report

    Report Number
    MW5155577
    Event Type
    Malfunction
    Date Received
    May 29, 2024
    Date of Event
    May 23, 2024
    Report Date
    May 24, 2024
    Manufacturer
    HILL-ROM, INC.
    Product Code
    IOQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    OVER 400 HILL-ROM BAXTER CENTRELLA BEDS WITH PRO+ MATTRESSES PURCHASED BETWEEN 2021 AND 2023 WERE NOTED TO HAVE EVIDENCE OF DE-LAMINATION ON OVER 100 MATTRESS COVERLETS. HILL-ROM BAXTER SALES REPRESENTATIVE ASSISTED IN REPLACING THE DE-LAMINATED COVERLETS UNDER WARRANTY WITH THE SAME COVERLET. WE WERE TOLD THAT THIS WAS A DIFFERENT COVERLET DESIGN OPTION WHICH WAS SUPPOSED TO REMEDY THE SITUATION. EVIDENCE OF DE-LAMINATION IS NOW OCCURRING ON THE REPLACED COVERLETS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329797 HILLROM BAXTER CENTRELLA BEDS WITH PRO+ MATTRESSES BED, FLOTATION THERAPY, POWERED IOQ HILL-ROM, INC. P723A01

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown