BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT DUAL-HEATED WITH EVAQUA BREATHING CIRCUIT

    MDR report key: 2853803 · Received December 3, 2012

    Report

    Report Number
    9611451-2012-00879
    Event Type
    Malfunction
    Date Received
    December 3, 2012
    Date of Event
    November 1, 2012
    Report Date
    November 5, 2012
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BZE
    PMA / PMN Number
    K983112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT RT340 ADULT DUAL-HEATED WITH EVAQUA BREATHING CIRCUIT IS EN ROUTE TO FISHER & PAYKEL HEALTHCARE FOR INVESTIGATION. WE WILL PROVIDE A FOLLOW-UP REPORT ONCE WE HAVE COMPLETED OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT RT340 ADULT DUAL-HEATED WITH EVAQUA BREATHING CIRCUIT WAS NOT RETURNED TO FISHER & PAYKEL HEALTHCARE FOR INVESTIGATION, AS IT WAS LOST BY THE DISTRIBUTOR. WITHOUT THE COMPLAINT DEVICE, WE ARE UNABLE TO VERIFY THE ALLEGED FAULT NOR DETERMINE THE ROOT CAUSE OF THE INCIDENT. AN ATTEMPT WAS MADE TO OBTAIN FURTHER INFORMATION ABOUT THE REPORTED INCIDENT; HOWEVER, THE INFORMATION THAT WE RECEIVED FROM THE HOSPITAL WAS NOT SUFFICIENT TO CONCLUDE THE ROOT CAUSE OF THE REPORTED FAULT. ALL ADULT BREATHING CIRCUITS ARE VISUALLY INSPECTED BEFORE LEAVING THE PRODUCTION LINE, AND THOSE THAT FAIL ARE REJECTED. OUR USER INSTRUCTIONS THAT ACCOMPANY THE RT340 ADULT BREATHING CIRCUIT STATE THE FOLLOWING: "CHECK ALL CONNECTIONS ARE TIGHT BEFORE USE." "PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM AND CHECK FOR OCCLUSIONS BEFORE CONNECTING TO A PATIENT." "CHECK THAT THE HEATER WIRE IS EVENLY DISTRIBUTED ALONG THE CIRCUIT AND NOT BUNCHED OR KINKED." "SET APPROPRIATE VENTILATOR ALARM."

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO A DISTRIBUTOR THAT AN RT340 ADULT DUAL-HEATED WITH EVAQUA BREATHING CIRCUIT HAD A DISCONNECTED HEATER WIRE AND A FAULTY EXPIRATORY LIMB. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO A DISTRIBUTOR THAT AN RT340 ADULT DUAL-HEATED WITH EVAQUA BREATHING CIRCUIT HAD A DISCONNECTED HEATER WIRE AND A FAULTY EXPIRATORY LIMB. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADULT DUAL-HEATED WITH EVAQUA BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LIMITED RT340 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1