BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HILLROM VERSACARE P500 MATTRESS

    MDR report key: 20419510 · Received October 9, 2024

    Report

    Report Number
    MW5160913
    Event Type
    Malfunction
    Date Received
    October 9, 2024
    Report Date
    October 4, 2024
    Manufacturer
    HILLROM / HILL-ROM, INC.
    Product Code
    IOQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    (B)(6) ISSUED SAFETY ALERT AL24-01 REGARDING FLUID INGRESS AND EGRESS FROM INPATIENT AND OUTPATIENT MATTRESSES CAN LEAD TO HOSPITAL-ASSOCIATED INFECTIONS, PATIENT TISSUE DEGRADATION, AND/OR PATIENT DEATH. WE HAVE NOT ATTRIBUTED ANY ADVERSE EVENTS TO OUR COMPROMISED MATTRESSES BUT HAVE BEEN INSTRUCTED TO PLACE FDA MEDWATCH FOR ALL COMPROMISED MATTRESSES. HILL-ROM VERSACARE P500 MATTRESS, 9 COMPROMISED WITH FLUID EGRESS. REFERENCE REPORTS MW5160907, MW5160908, MW5160909, MW5160910, MW5160911, MW5160912, MW5160914, MW5160915.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295754 HILLROM VERSACARE P500 MATTRESS BED, FLOTATION THERAPY, POWERED IOQ HILLROM / HILL-ROM, INC. P3254B2

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown