BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCTICSUN GEL PADS

    MDR report key: 6144253 · Received December 5, 2016

    Report

    Report Number
    1018233-2016-01746
    Event Type
    Malfunction
    Date Received
    December 5, 2016
    Report Date
    November 14, 2016
    Manufacturer
    PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590
    Product Code
    DWJ
    PMA / PMN Number
    K142702
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE DEVICE HISTORY RECORD WAS REVIEWED AND FOUND NOTHING THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE INSTRUCTIONS FOR USE STATE THE FOLLOWING: ¿ONCE THE PADS ARE PRIMED, ASSURE THE FLOW RATE DISPLAYED ON THE CONTROL PANEL IS GREATER THAN 2.3 LITERS PER MINUTE, WHICH IS THE MINIMUM FLOW RATE FOR A FULL PAD KIT.¿ (B)(4). THE DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SET OF 4 MEDIUM PADS WERE GIVING LOW FLOW. THE FLOW WITH THE SHUNT TUBE WAS 3.3LPM ON ONE VALVE SET. THE SET OF 4 MEDIUM PADS WERE SWAPPED WITH A SECOND SET OF 4 MEDIUM PADS AND THE ISSUE OF LOW FLOW REOCCURRED. THE PADS WERE DISCONNECTED AND RECONNECTED WHICH ALLOWED THE FLOW TO SETTLE AROUND 1.9 TO 2.0 LPM. THERAPY WAS CONTINUED USING THE SECOND SET OF PADS WITHOUT ANY FURTHER ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    796346 ARCTICSUN GEL PADS ARCTICSUN GEL PADS DWJ PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590 NGAU0844

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention