BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT DUAL HEATED EVAQUA BREATHING CIRCUIT

    MDR report key: 3496064 · Received December 2, 2013

    Report

    Report Number
    9611451-2013-00970
    Event Type
    Malfunction
    Date Received
    December 2, 2013
    Date of Event
    November 6, 2013
    Report Date
    November 7, 2013
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BZE
    PMA / PMN Number
    K034026
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT RT235 INFANT DUAL HEATED EVAQUA BREATHING CIRCUITS HAD BEEN DISCARDED AT THE HEALTHCARE FACILITY. WE ARE CURRENTLY IN THE PROCESS OF OBTAINING FURTHER INFORMATION FROM THE HEALTHCARE FACILITY IN ORDER TO ASSIST US WITH THE ANALYSIS AND IDENTIFICATION OF A POSSIBLE ROOT CAUSE OF THE REPORTED EVENT. WE WILL PROVIDE A FOLLOW UP REPORT ONCE WE RECEIVE FURTHER INFORMATION AND HAVE COMPLETED OUR ANALYSIS.

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT RT235 INFANT DUAL HEATED EVAQUA BREATHING CIRCUITS HAD BEEN DISCARDED AT THE HEALTHCARE FACILITY. AN ATTEMPT WAS MADE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORTED CRACKING OF THE EXPIRATORY LIMBS BUT NO REPLY WAS RECEIVED FROM THE HEALTHCARE FACILITY. WITHOUT THE COMPLAINT DEVICE OR ADDITIONAL INFORMATION, WE ARE UNABLE TO CONFIRM AND DETERMINE THE ROOT CAUSE OF THE REPORTED FAULT. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 090831. OUR USER INSTRUCTIONS THAT ACCOMPANY THE RT235 INFANT DUAL HEATED EVAQUA BREATHING CIRCUITS 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." "SET APPROPRIATE VENTILATOR ALARMS." THE STAFF AT THE HEALTHCARE FACILITY CORRECTLY CHECKED THE SUBJECT BREATHING CIRCUIT BEFORE PATIENT USE, WHICH IS IN LINE WITH OUR USER INSTRUCTIONS.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT THE EXPIRATORY LIMBS OF THREE RT235 INFANT DUAL HEATED EVAQUA BREATHING CIRCUITS WERE CRACKED. THIS WAS OBSERVED BEFORE USE ON A PATIENT. IT WAS ALSO REPORTED THAT THE COMPLAINT DEVICES WERE DISCARDED AT THE HEALTHCARE FACILITY.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT THE EXPIRATORY LIMBS OF THREE RT235 INFANT DUAL HEATED EVAQUA BREATHING CIRCUITS WERE CRACKED. THIS WAS OBSERVED BEFORE USE ON A PATIENT. IT WAS ALSO REPORTED THAT THE COMPLAINT DEVICES WERE DISCARDED AT THE HEALTHCARE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622763 INFANT DUAL HEATED EVAQUA BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LIMITED RT235 090831

    Patients

    Seq Age Sex Outcome Treatment
    1