BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCTICGEL PADS

    MDR report key: 7028467 · Received November 14, 2017

    Report

    Report Number
    1018233-2017-05857
    Event Type
    Malfunction
    Date Received
    November 14, 2017
    Report Date
    January 26, 2018
    Manufacturer
    MEDIVANCE, INC. ¿ 1725056
    Product Code
    DWJ
    PMA / PMN Number
    K142702
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    RECEIVED 1 ARTIC GEL PAD KIT. THE REPORTED ISSUE FOR THIS COMPLAINT IS UNCONFIRMED, DURING VISUAL EVALUATION THE PADS WERE INSPECTED AND FOUND TO HAVE THE TRIM PATTERN CORRECTLY PERFORMED, THE PLASTIC TUBES WERE FOUND COMPLETELY ASSEMBLED COVERING THE TOTAL OF CLAMPING RINGS ON THE PLASTIC CONNECTOR AND MANIFOLD CONNECTOR, THE FOAMS WERE FOUND FREE OF DAMAGES, TEARS OR PERFORATIONS, THE SEAL BETWEEN MANIFOLD CONNECTOR AND PAD WAS FOUND COMPLETELY SEALED, THE ENERGY CONNECTORS WERE FOUND FREE OF DAMAGES, IT WAS NOTED THAT THERE WAS EVIDENCE OF THE SEALING PRESENT ON THE PADS. NO MANUFACTURING ISSUES RELATED WERE NOTED DURING THE VISUAL EVALUATION OF THE PADS RETURNED. THE FLOW RATE WAS FOUND TO BE ACCEPTABLE ON ALL OF THE RETURNED PADS. THE FLOW RATE FOR THIS PRODUCT MUST BE ABOVE 2.4 L/MIN M2. 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: ¿6. 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 FULLPAD KIT.¿ (B)(4).

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE FLOW RATE WAS NOT ABLE TO EXCEED 1LPM DURING USE ON A PATIENT. THE NURSE REPORTED THAT THEY TRIED TROUBLESHOOTING THE PADS BY DISCONNECTING THEM AND RECONNECTING THEM AND CHECKING THE LINES FOR KINKS. SHE STATED THAT THEY ALSO TRIED A SECOND ARCTIC SUN DEVICE BUT THAT THEY SAW NO IMPROVEMENT IN THE FLOW RATE. THEY THEN SWAPPED THE PADS OUT FOR A SECOND SET OF PADS. THIS CORRECTED THE ISSUE AND THEY WERE ABLE TO GET AN OPTIMAL FLOW RATE. THE PATIENT WAS ABLE TO COMPLETE THERAPY WITH THE SECOND SET OF PADS WITHOUT FURTHER ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE FLOW RATE WAS NOT ABLE TO EXCEED 1LPM DURING USE ON A PATIENT. THE NURSE REPORTED THAT THEY TRIED TROUBLESHOOTING THE PADS BY DISCONNECTING THEM AND RECONNECTING THEM AND CHECKING THE LINES FOR KINKS. SHE STATED THAT THEY ALSO TRIED A SECOND ARCTIC SUN DEVICE BUT THAT THEY SAW NO IMPROVEMENT IN THE FLOW RATE. THEY THEN SWAPPED THE PADS OUT FOR A SECOND SET OF PADS. THIS CORRECTED THE ISSUE AND THEY WERE ABLE TO GET AN OPTIMAL FLOW RATE. THE PATIENT WAS ABLE TO COMPLETE THERAPY WITH THE SECOND SET OF PADS WITHOUT FURTHER ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    811145 ARCTICGEL PADS ARCTIC SUN GEL PADS DWJ MEDIVANCE, INC. ¿ 1725056 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1