BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HILL-ROM, INC.

    MDR report key: 19941635 · Received August 7, 2024

    Report

    Report Number
    MW5158199
    Event Type
    Malfunction
    Date Received
    August 7, 2024
    Date of Event
    September 16, 2019
    Report Date
    August 2, 2024
    Manufacturer
    HILL-ROM CENTRELLA BED
    Product Code
    IOQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE ENTRAPMENT ROD ON THE HILL-ROM CENTRELLA BED HAS CAUSED THE BOTTOM MATTRESS COVER TO BECOME STUCK AND RIP. THE RIP IN THE MATTRESS COVER ALLOWS FOR FLUID INTRUSION INTO THE MATTRESS WHICH IS A MAJOR INFECTION PREVENTION ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1805815 HILL-ROM, INC. BED, FLOTATION THERAPY, POWERED IOQ HILL-ROM CENTRELLA BED

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other