BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEDIATRIC BREATHING CIRCUIT

    MDR report key: 3345865 · Received August 23, 2013

    Report

    Report Number
    1718887-2013-00004
    Event Type
    Malfunction
    Date Received
    August 23, 2013
    Date of Event
    July 24, 2013
    Report Date
    July 26, 2013
    Manufacturer
    VITAL SIGNS COLORADO, INC.
    Product Code
    OFP
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A CUSTOMER LETTER WILL BE DELIVERED TO ALL AFFECTED CUSTOMERS DESCRIBING THE ISSUE AND THE APPROPRIATE ACTION TO BE TAKEN. THE FIELD ACTION WAS INITIATED 12/12/2013 AND WILL BE REPORTED TO FDA IN ACCORDANCE WITH 21 CFR 806.10. GE HEALTHCARE HAS NOT YET ASSIGNED A CORRECTION NUMBER. NO SAMPLE WAS RETURNED, HOWEVER A PHOTO OF THE CAP INVOLVED WAS PROVIDED TO FURTHER THE INVESTIGATION. THE PRIMARY ROOT CAUSE OF THE REPORTED EVENT IS THE "CIRCUIT AIR TEST METHOD" USED DURING ASSEMBLY TESTING MAY RESULT IN LEAVING THE CAP ON THE CIRCUIT AFTER ASSEMBLY. IF THE CAP IS LEFT IN PLACE, IT COULD OCCLUDE THE CIRCUIT AND PREVENT OXYGEN AND ANESTHESIA FLOW TO THE PATIENT. CORRECTION: THE CIRCUIT AIR TEST HAS BEEN UPDATED WITH INSTRUCTIONS TO REMOVE THE CAPS AFTER THE TEST IS COMPLETE. THE CAPS USED FOR THE CIRCUIT AIR TEST HAVE BEEN REPLACED WITH A CAP THAT CAN BE PERMANENTLY ATTACHED TO THE TEST EQUIPMENT SO THAT IT CANNOT BE LEFT ON THE CIRCUIT.

    Additional Manufacturer Narrative · 1

    PRODUCT LOT NUMBER HAS NOT BEEN CONFIRMED, THEREFORE, DEVICE MANUFACTURE DATE IS UNK. THE CUSTOMER REPORTED THAT LOT # 6270A WAS IN INVENTORY, BUT IT IS UNK IF THAT IS THE LOT INVOLVED IN THE REPORTED EVENT. GE HEALTHCARE'S INVESTIGATION IS ONGOING. A F/U REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A BLUE CAP OCCLUDED THE INSPIRATORY END OF THE PEDIATRIC BREATHING CIRCUIT AT THE CUFF, PREVENTING OXYGEN AND ANESTHESIA FLOW TO THE PT. DURING INHALATION, INDUCTION ON A PEDIATRIC PT UNDERGOING ADENOIDECTOMY, TONSILLECTOMY, AND BILATERAL MYRINGOTOMY PROCEDURE, THE PT'S SAO2 LEVEL DROPPED TO THE 70'S. THE PT WAS NOT FALLING ASLEEP AND SURGERY HAD NOT YET STARTED. THE PT WAS SWITCHED TO AN AMBU BAG, VENTILATION WAS INITIATED, AND THE INSPIRATORY CIRCUIT WAS REMOVED. THE CIRCUIT WAS CHECKED AND IT WAS REPORTED THAT, "THE CAP WAS ON THE END OF THE CIRCUIT WHERE IT PLUGGED INTO THE ANESTHESIA MACHINE; FITTING INSIDE THE PORT ON THE ANESTHESIA MACHINE." THE CAP WAS REMOVED AND THE CASE RESUMED. IT WAS REPORTED THAT THE EVENT WAS APPROX 10 - 15 SECONDS IN DURATION, THE PT WAS NOT GIVEN ANY MEDICATION AS A RESULT OF THE EVENT, THERE WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244893 PEDIATRIC BREATHING CIRCUIT CIRCUIT, BREATHING OFP VITAL SIGNS COLORADO, INC. 1552016

    Patients

    Seq Age Sex Outcome Treatment
    1 Female