BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HERCULES

    MDR report key: 20344427 · Received September 30, 2024

    Report

    Report Number
    MW5160340
    Event Type
    Malfunction
    Date Received
    September 30, 2024
    Date of Event
    April 18, 2024
    Report Date
    September 25, 2024
    Manufacturer
    THE MOREL COMPANY
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WV, US
    Reporter Occupation
    501
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    A FACILITY REPORTED THE PRESENCE OF BLOOD INSIDE HOSPITAL MATTRESSES DUE TO PINHOLES IN THE MATERIAL (COVERING). THE FLUID INFILTRATION WAS DISCOVERED IN 37 MATTRESSES WHEN THE COVERS WERE SEPARATED AWAY FROM THE FOAM INSERT DURING PREVENTATIVE MAINTENANCE INSPECTIONS OF BEDS AND MATTRESSES. THE COMPROMISED MATTRESSES WERE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1870814 HERCULES BED, AC-POWERED ADJUSTABLE HOSPITAL FNL THE MOREL COMPANY

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other