BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEVEL 1®HOTLINE® 3 BLOOD AND FLUID WARMER

    MDR report key: 8446373 · Received March 22, 2019

    Report

    Report Number
    3012307300-2019-01518
    Event Type
    Malfunction
    Date Received
    March 22, 2019
    Report Date
    February 5, 2020
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    BSB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    EVALUATION RESULTS: THE HL-90 WAS RECEIVED IN FAIR CONDITION AND WAS MANUFACTURED IN 2015. THE DEVICE WAS FILLED WITH WATER, FITTED WITH TEMP CHECK E5580 DUE (B)(6) 2019, AND POWERED ON. ALL ALARMS WERE ACTIVATED AND APPEARED TO WORK VISUALLY WITH THE LED'S BUT THERE WAS NO AUDIBLE SOUND CONFIRMING THE CUSTOMER COMPLAINT. AFTER THE PCB PN 7012091 WAS REPLACED THE ALARMS WORKED FINE AND THE DEVICE OPERATED AS INTENDED. THE PROBLEM SOURCE OF THE REPORTED PRODUCT PROBLEM WAS UNKNOWN. A ROOT CAUSE WAS NOT ESTABLISHED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL FLUID WARMER HAS NO AUDIBLE ALARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237266 LEVEL 1®HOTLINE® 3 BLOOD AND FLUID WARMER WARMER, BLOOD, NON-ELECTROMAGNETIC RADIATION BSB SMITHS MEDICAL ASD, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1