BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON RCI AQUATHERM III EXTERNAL ELECTRIC HEATER

    MDR report key: 25046381 · Received April 30, 2026

    Report

    Report Number
    1417592-2026-00640
    Event Type
    Malfunction
    Date Received
    April 30, 2026
    Date of Event
    March 31, 2026
    Report Date
    April 30, 2026
    Manufacturer
    MEDLINE INDUSTRIES, LP
    Product Code
    CAF
    UDI-DI
    10197344011629
    PMA / PMN Number
    K223100
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PER REPORT, "PAM HEALTH SPECIALITY HOSPITAL HEALTH OF DENVER PURCHASED UNITS. CUSTOMER REPORTS 2 UNITS NOT HEATING UP AND ONE HAS CRACK IN CASING AW8269."THERE WERE NO REPORTS OF DEATH, SERIOUS INJURY, MEDICAL INTERVENTION, OR FOLLOW UP CARE. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT COULD CAUSE OR CONTRIBUTE TO SERIOUS INJURY IF IT WERE TO OCCUR AGAIN. IN AN ABUNDANCE OF CAUTION, THIS MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 0

    PER REPORT, "PAM HEALTH SPECIALITY HOSPITAL HEALTH OF DENVER PURCHASED UNITS. CUSTOMER REPORTS 2 UNITS NOT HEATING UP AND ONE HAS CRACK IN CASING AW8269."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162821 HUDSON RCI AQUATHERM III EXTERNAL ELECTRIC HEATER AQUATHERM III HEATER,ADJUST,LVN CAF MEDLINE INDUSTRIES, LP 10197344011629

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown