BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCTIC SUN GEL PAD

    MDR report key: 6155992 · Received December 8, 2016

    Report

    Report Number
    1018233-2016-01769
    Event Type
    Malfunction
    Date Received
    December 8, 2016
    Date of Event
    August 15, 2016
    Report Date
    January 19, 2017
    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
    JA
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD.

    Additional Manufacturer Narrative · 1

    RECEIVED 1 USED UNIVERSAL PAD ONLY. THE REPORTED EVENT WAS UNCONFIRMED, AS THE PROBLEM COULD NOT BE REPRODUCED. THE VISUAL INSPECTION NOTED NO OBVIOUS DEFECTS THAT WOULD HAVE CONTRIBUTED TO THE REPORTED PROBLEM. THE PAD WAS REVIEWED AND USE EVIDENCE WAS NOTED. THE PAD 'S TRIM PATTERN WAS FOUND TO BE CORRECT. THE ENERGY CONNECTOR WAS FOUND FREE OF DAMAGES AND PRESENTED A GOOD CONNECTION. THE FUNCTIONAL EVALUATION WAS CONDUCTED AS FOLLOWS: THE PAD WAS SUBMITTED TO THE FLOW RATE TEST UNDER TEST METHOD TM7600515 WITH THE ARCTIC SUN MACHINE MODEL 2000 THE PAD WAS CONNECTED TO THE ARCTIC SUN MACHINE MODEL 2000 DURING 10 MINUTES, SEE DETAILS BELOW: * UNIVERSAL PAD: A TOTAL OF 5.15 L/MIN M2 OF FLOW RATE WERE REGISTERED DURING THE TEST. ACCORDING THE TEST METHOD TM7600515 THE FLOW RATE WAS FOUND TO BE ACCEPTABLE ON THE RETURNED PAD. 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): "L" (B)(4): "NL" THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWO SINGLE UNIVERSAL PADS, USED ON A PEDIATRIC PATIENT, HAD LOW FLOW. THE FIRST PAD HAD A FLOW OF ABOUT 0.5 LPM; AS A RESULT, THE PAD WAS SWAPPED WITH A NEW PAD . HOWEVER, THAT PAD ALSO HAD LOW FLOW. THE THERAPY WAS CONTINUED AND COMPLETED WITH THE TWO ALLEGED LOW FLOW PADS CONNECTED TO THE FLUID DELIVERY LINE. THE FLOW OF THE TWO PADS COMBINED WAS ABOUT 1.1 LPM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWO SINGLE UNIVERSAL PADS, USED ON A PEDIATRIC PATIENT, HAD LOW FLOW. THE FIRST PAD HAD A FLOW OF APPROXIMATELY 0.5 LPM; AND AS A RESULT, THE PAD WAS REPLACED WITH A NEW PAD . HOWEVER, THE REPLACEMENT PAD ALSO HAD LOW FLOW. THE THERAPY WAS CONTINUED AND COMPLETED WITH THE TWO PADS (THAT ALLEGEDLY PRODUCED LOW FLOW ), CONNECTED TO THE FLUID DELIVERY LINE. THE FLOW OF THE TWO PADS COMBINED WAS APPROXIMATELY 1.1 LPM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWO SINGLE UNIVERSAL PADS, USED ON A PEDIATRIC PATIENT, HAD LOW FLOW. THE FIRST PAD HAD A FLOW OF APPROXIMATELY 0.5 LPM; AND AS A RESULT, THE PAD WAS REPLACED WITH A NEW PAD . HOWEVER, THE REPLACEMENT PAD ALSO HAD LOW FLOW. THE THERAPY WAS CONTINUED AND COMPLETED WITH THE TWO PADS (THAT ALLEGEDLY PRODUCED LOW FLOW), CONNECTED TO THE FLUID DELIVERY LINE. THE FLOW OF THE TWO PADS COMBINED WAS APPROXIMATELY 1.1 LPM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWO SINGLE UNIVERSAL PADS, USED ON A PEDIATRIC PATIENT, HAD LOW FLOW. THE FIRST PAD HAD A FLOW OF APPROXIMATELY 0.5 LPM; AND AS A RESULT, THE PAD WAS REPLACED WITH A NEW PAD . HOWEVER, THE REPLACEMENT PAD ALSO HAD LOW FLOW. THE THERAPY WAS CONTINUED AND COMPLETED WITH THE TWO PADS (THAT ALLEGEDLY PRODUCED LOW FLOW ), CONNECTED TO THE FLUID DELIVERY LINE. THE FLOW OF THE TWO PADS COMBINED WAS APPROXIMATELY 1.1 LPM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    806164 ARCTIC SUN GEL PAD ARCTIC SUN SUN GEL PAD UNIVERSAL DWJ PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590 NGAN4034

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention