BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEVEL 1 HOTLINE LOW FLOW SYSTEM (HL-390)

    MDR report key: 10185259 · Received June 23, 2020

    Report

    Report Number
    3012307300-2020-06191
    Event Type
    Malfunction
    Date Received
    June 23, 2020
    Report Date
    July 21, 2020
    Manufacturer
    ST PAUL
    Product Code
    LGZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ONE FLUID WARMER WAS RETURNED FOR EVALUATION. A DHR REVIEW WAS PERFORMED SUBSEQUENT TO THE MANUFACTURING OF THE DEVICE AND PRIOR TO ITS RELEASE; NO PROBLEMS OR ISSUES WERE IDENTIFIED DURING THIS DHR REVIEW. VISUAL INSPECTION OF THE DEVICE FOUND IT TO BE IN GOOD PHYSICAL CONDITION. DEVICE UNDERWENT FUNCTIONAL TESTING, BY FILLING TANK WITH WATER AND POWERING IT ON. THE REPORTED CUSTOMER COMPLAINT HAS BEEN CONFIRMED, DUE TO A FAULTY PCB. IT WAS ALSO NOTED THAT NO ALARMS SOUNDED BECAUSE OF THE FAULTY PCB.

    Description of Event or Problem · 0

    RO 1070905: ALL THE ALARM BUTTON ARE NOT WERE NOT WORKING WHEN RECEIVED. ADDITIONAL INFORMATION RECEIVED 12 JUNE 2020: DEVICE ALARMS WERE NOT OPERATIONAL. NO ADDITIONAL INFORMATION KNOWN.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION IN PROGRESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BUTTONS ON THE LEVEL 1 HOTLINE LOW FLOW SYSTEM (HL-390) WERE NOT WORKING. THE DEVICE ALARMS WERE NOT OPERATIONAL. THESE ISSUES WERE DISCOVERED DURING TESTING. NO PATIENT INJURY OR COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    649218 LEVEL 1 HOTLINE LOW FLOW SYSTEM (HL-390) WARMER, THERMAL, INFUSION FLUID LGZ ST PAUL HL-390

    Patients

    Seq Age Sex Outcome Treatment
    1