BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOTLINE® 3 FLUID WARMER

    MDR report key: 7515544 · Received May 15, 2018

    Report

    Report Number
    3012307300-2018-01528
    Event Type
    Malfunction
    Date Received
    May 15, 2018
    Report Date
    September 4, 2018
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    LGZ
    UDI-DI
    10695085002796
    PMA / PMN Number
    K911383
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE HOTLINE 3 FLUID WARMER 115V, WAS RECEIVED IN HEAVILY USED CONDITION. THE DEVICE WAS OBSERVED TO BE LEAKING FROM THE WATER RESERVOIR DUE TO A CRACKED TANK COVER. AN INTERLOCK SWITCH, ALARM TEST SWITCH, AND A FLOAT SWITCH TEST WERE ALL PERFORMED. THERE WAS NO AUDIBLE ALARM AFTER THESE TESTS. A TEST BOARD WAS THEN USED TO PERFORM ALL THE RELEVANT AUDIBLE TEST. ALL THE TESTS PASSED AFTER THIS. THE MAIN PCB PART (NUMBER 7012091) WAS FOUND TO BE THE FAULTY COMPONENT IN THE END. THE CUSTOMER REASON FOR THE PRODUCT RETURN WAS THEREFORE CONFIRMED.

    Description of Event or Problem · 1

    USER FACILITY REQUESTED REPAIR OF A FLUID WARMER SYSTEM DUE TO "NO AUDIBLE ALARM". NO PATIENT DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    356943 HOTLINE® 3 FLUID WARMER WARMER, THERMAL, INFUSION FLUID LGZ SMITHS MEDICAL ASD, INC. 3 10695085002796

    Patients

    Seq Age Sex Outcome Treatment
    1