BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTRELLA PRO+ 36"

    MDR report key: 19428683 · Received May 29, 2024

    Report

    Report Number
    MW5155578
    Event Type
    Malfunction
    Date Received
    May 29, 2024
    Date of Event
    May 23, 2024
    Report Date
    May 24, 2024
    Manufacturer
    HILL-ROLM INC / 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

    PRO+ BLOWER REMEDIATION PROJECT (REFERENCE NUMBER FA-2022-026) ANNOUNCED IN JUNE 2022 COMPLETED BY HILL-ROM. RELATED TO REDUCTION IN THE PERFORMANCE OF THE MICROCLIMATE MANAGEMENT (MCM) FEATURE OF THE PRO+ MATTRESS. MCM IS USED TO PULL HEAT AND MOISTURE AWAY FROM THE PATIENT. SINCE THEN, HAVE FOUND DISCONNECTED BLOWER AIR HOSE ON 40 OF OVER 400 HILL-ROM CENTRELLA BEDS WITH PRO + MATTRESSES PURCHASED FROM 2021-2023. THE MATTRESS BLOWER HOSES EITHER CAME UNDONE OR WERE NEVER CONNECTED AT THE FACTORY - A MANUFACTURING DEFECT RESULTING IN NO AIRFLOW AND THE MATTRESS LOSES ITS "LOW AIR-LOSS" FEATURE. HILL-ROM HAS NO OFFICIAL FIX OR REDESIGN FOR THIS ISSUE. BIOMEDICAL DEPARTMENT IS SECURING AIR HOSES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329798 CENTRELLA PRO+ 36" BED, FLOTATION THERAPY, POWERED IOQ HILL-ROLM INC / HILL-ROM, INC. P7923A01

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown