BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRESSA

    MDR report key: 20335924 · Received September 27, 2024

    Report

    Report Number
    MW5160306
    Event Type
    Malfunction
    Date Received
    September 27, 2024
    Date of Event
    April 18, 2024
    Report Date
    September 24, 2024
    Manufacturer
    HILL ROM / HILL-ROM, INC.
    Product Code
    IOQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WV, US
    Reporter Occupation
    501
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    UNDETECTED FLUID INGRESS AND EGRESS FROM INPATIENT AND OUTPATIENT MATTRESSES CAN LEAD TO HOSPITAL-ASSOCIATED INFECTIONS, PATIENT TISSUE DEGRADATION, AND/OR PATIENT DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46147 PROGRESSA BED, FLOTATION THERAPY, POWERED IOQ HILL ROM / HILL-ROM, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other PROGRESSA 1: (B)(6)/2019-(B)(6)/2024.| PROGRESSA 2: (B)(6)2019-(B)(6)2024.| PROGRESSA 3: (B)(6)2019-(B)(6)2024.| PROGRESSA 4: (B)(6)2019-(B)(6)2024.