BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON 780-98 CIRCUIT W/ COLUMN

    MDR report key: 6169792 · Received December 13, 2016

    Report

    Report Number
    3004365956-2016-00451
    Event Type
    Malfunction
    Date Received
    December 13, 2016
    Date of Event
    November 22, 2016
    Report Date
    November 28, 2016
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    OGG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A VISUAL, DIMENSIONAL, AND FUNCTIONAL INSPECTION OF THE DEVICE INVOLVED IN THE COMPLAINT COULD NOT BE CONDUCTED SINCE THE DEVICE WAS NOT RETURNED AT THE TIME OF THIS REPORT. A DEVICE HISTORY RECORD REVIEW COULD NOT BE CONDUCTED SINCE THE LOT NUMBER WAS NOT PROVIDED. CUSTOMER COMPLAINT CANNOT BE CONFIRMED BASED ONLY ON THE INFORMATION PROVIDED. TO PERFORM A PROPER INVESTIGATION, AND DETERMINE THE SOURCE OF THE ALLEGED DEFECT, IT IS NECESSARY TO EVALUATE THE DEVICE INVOLVED IN THIS COMPLAINT. HOWEVER MATERIAL FROM THE PRODUCTION LINE WAS INSPECTED , AND NO ISSUES WERE DETECTED THAT CAN BE ASSOCIATED WITH THIS CUSTOMER COMPLAINT. IF THE DEVICE SAMPLE BECOMES AVAILABLE AT A LATER DATE THIS COMPLAINT WILL UPDATED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS RETURNED FOR EVALUATION. UPON RECEIPT THE VENTILATOR CIRCUIT WAS VISUALLY EXAMINED FOR ANY DAMAGE THAT MIGHT HAVE BEEN CAUSED FROM ABUSE/MISUSE/AND/OR SUBJECTED TO ANY TOXIC ENVIRONMENTS THAT COULD CAUSE PHYSICAL OR CHEMICAL DAMAGE TO THE DEVICE. THE MELTED AREA OF THE CIRCUIT WAS IDENTIFIED AND CONFIRMED. IT IS LOCATED APPROXIMATELY IN THE MIDDLE OF THE INSPIRATORY LIMB. THE MELTED AREA OF THE TUBE IS APPROXIMATELY EIGHT (8) INCHES LONG AND IS SEVERE. NO CHARRING OR BURNING OF THE HEATED WIRES OR CIRCUIT TUBING CAN BE SEEN IN THE CIRCUIT, ESPECIALLY AT THE SITE OF THE MELT. THE ELECTRICAL RESISTANCE WAS MEASURED AND FOUND TO BE WITHIN SPECIFICATION. THE COMPLAINT WAS CONFIRMED. HOWEVER, ALL CIRCUITS ARE 100% FUNCTIONALLY TESTED AND 100% VISUALLY INSPECTED FOR PROPER OPERATION AT THE TIME OF MANUFACTURING, SO IT IS UNLIKELY THAT THIS DEFECT WAS PRESENT AT THAT TIME. THE COMPLAINT REPORT STATES THAT THE CIRCUIT WAS PRE-TESTED PRIOR TO USE ON A PATIENT. NORMAL PRE-TEST CONDITIONS ARE RESTRICTED TO SST TESTING (LEAK TESTING). IF THIS CIRCUIT WAS ELECTRICALLY CONNECTED TO A NEPTUNE FOR PRETEST, THE ABSENCE OF GAS FLOW COULD HAVE CAUSED THE MELTING EVENT. OTHER REMARKS: THE IFU STATES, "CONTINUOUS FLOW IS REQUIRED FOR SAFE OPERATION". ALSO, THE IFU WARNS, "DO NOT PLACE TUBING DIRECTLY ON PATIENT'S SKIN", "AND DO NOT COVER TUBING WITH SHEETS, BLANKETS, TOWELS, CLOTHING, OR OTHER MATERIALS". CORRECTIVE ACTION IS NOT REQUIRED AT THIS TIME AS THE DAMAGE OBSERVED ON THE CIRCUIT AND THE DESCRIBED CIRCUMSTANCES OF USE AT THE TIME OF DISCOVERY INDICATE THAT OPERATIONAL CONTEXT CAUSED OR CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 1

    CUSTOMER COMPLAINT ALLEGES THAT THE "CIRCUIT MELTED ABOUT HALFWAY DOWN." THE ALLEGED DEFECT WAS REPORTED AS BEING DETECTED IN A "PRE TEST". NO PATIENT INVOLVEMENT WAS REPORTED.

    Description of Event or Problem · 1

    CUSTOMER COMPLAINT ALLEGES THAT THE "CIRCUIT MELTED ABOUT HALFWAY DOWN." THE ALLEGED DEFECT WAS REPORTED AS BEING DETECTED IN A "PRE TEST". NO PATIENT INVOLVEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    821925 HUDSON 780-98 CIRCUIT W/ COLUMN HUMIDIFIER NEBULIZER KIT OGG TELEFLEX MEDICAL UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1