BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFANT DUAL HEATED WITH EVAQUA BREATHING CIRCUIT

    MDR report key: 1891544 · Received November 4, 2010

    Report

    Report Number
    9611451-2010-00676
    Event Type
    Injury
    Date Received
    November 4, 2010
    Report Date
    October 13, 2010
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BZE
    PMA / PMN Number
    K034026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT RT235 INFANT DUAL-HEATED WITH EVAQUA BREATHING CIRCUIT IS EN ROUTE TO FISHER & PAYKEL HEALTHCARE FOR INVESTIGATION. WE ARE CURRENTLY IN THE PROCESS OF OBTAINING FURTHER INFORMATION FROM THE HOSPITAL IN ORDER TO ASSIST US WITH THE ANALYSIS AND IDENTIFICATION OF A POSSIBLE ROOT CAUSE OF THE EVENT AS REPORTED. WE WILL PROVIDE A FOLLOW UP REPORT ONCE WE RECEIVE FURTHER INFORMATION FROM THE HOSPITAL AND HAVE COMPLETED OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE INSPIRATORY LIMB OF AN RT235 BREATHING CIRCUIT AND A 900MR869 TEMPERATURE/FLOW PROBE WERE RETURNED TO FPH (B)(4) FOR INVESTIGATION. BOTH DEVICES WERE VISUALLY INSPECTED FOR THE REPORTED DAMAGE. THE INSPIRATORY LIMB OF AN RT235 BREATHING CIRCUIT WAS PERFORMANCE TESTED USING AN RT125 TEST BREATHING CIRCUIT AND A 900MR869 PROBE. RESULTS: THE RETURNED BREATHING CIRCUIT AND PROBE APPEARED NORMAL, WITH NO PHYSICAL DAMAGE NOTED. IT WAS POSSIBLE TO INSERT THE TEST TEMPERATURE PROBE FULLY INTO THE ELBOW PROBE PORT OF THE RETURNED RT235 INSPIRATORY LIMB. THE CONNECTION WAS TIGHT AND THE PROBE WAS NOT FALLING OUT OF THE PROBE PORT. IT WAS ALSO POSSIBLE TO INSERT THE RETURNED TEMPERATURE PROBE FULLY INTO THE ELBOW PROBE PORT OF THE TEST BREATHING CIRCUIT. AGAIN, THE CONNECTION WAS TIGHT AND THE PROBE WAS NOT FALLING OUT OF THE PROBE PORT. FINALLY, IT WAS POSSIBLE TO INSERT THE RETURNED TEMPERATURE PROBE FULLY INTO THE ELBOW PROBE PORT OF THE RETURNED RT235 INSPIRATORY LIMB. THE CONNECTION WAS TIGHT AND THE PROBE WAS NOT FALLING OUT OF THE PROBE PORT. CONCLUSION: NO FAULT WAS FOUND WITH EITHER THE BREATHING CIRCUIT OR THE PROBE. OUR USER INSTRUCTIONS WHICH ACCOMPANY THE RT235 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." IN ADDITION, THE INSTRUCTIONS PROVIDED WITH OUR TEMPERATURE PROBES ILLUSTRATE HOW TO INSERT THE PROBE AND TO ENSURE THAT THE PROBE HAS BEEN FULLY INSERTED INTO THE PORT. THE USER INSTRUCTIONS ALSO STATE THE FOLLOWING: "CHECK THAT ALL CONNECTIONS, CAPS AND/OR PLUGS ARE TIGHT BEFORE USE." FURTHER INFORMATION RECEIVED FROM THE HOSPITAL CONFIRMED THAT THE PATIENT IS NOW IN GOOD CONDITION. AN FPH FIELD REPRESENTATIVE OFFERED A TRAINING WITH THE HOSPITAL STAFF HOWEVER IT WAS DELAYED DUE TO THE LACK OF RESOURCES AT THE HOSPITAL.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THE FOLLOWING TO A FISHER & PAYKEL HEALTHCARE'S (FPH) FIELD REPRESENTATIVE IN FRANCE INVOLVING AN RT235 INFANT DUAL-HEATED WITH EVAQUA BREATHING CIRCUIT: "A TECHNICIAN FROM TIMONE HOSPITAL REPORTED "THAT THE TEMPERATURE PROBE (OUT OF THE CHAMBER) WOULDN'T STAY IN THE TEMPERATURE PORT OF THE BREATHING CIRCUIT WHICH IT WOULD CAUSE A CARDIAC ARREST TO THE PATIENT." " IT WAS ALSO REPORTED "THAT THE STAFF WOULDN'T REACT AT THE VENTILATOR ALARMS WHEN THIS TYPE OF EVENT OCCURS. THEY WOULD TAKE ACTION ONLY WHEN THE MONITORING DEVICES ALARMS." "FURTHER INFORMATION RECEIVED FROM THE HOSPITAL REVEALED THAT THE "BRADYCARDIA QUICKLY FIXED WITH HABIT".

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THE FOLLOWING TO A FISHER & PAYKEL HEALTHCARE'S (FPH) FIELD REPRESENTATIVE IN (B)(4) INVOLVING AN RT235 INFANT DUAL-HEATED WITH EVAQUA BREATHING CIRCUIT: A TECHNICIAN FROM (B)(6) HOSPITAL REPORTED "THAT THE TEMPERATURE PROBE (OUT OF THE CHAMBER) WOULDN'T STAY IN THE TEMPERATURE PORT OF THE BREATHING CIRCUIT WHICH IT WOULD CAUSE A CARDIAC ARREST TO THE PATIENT." IT WAS ALSO REPORTED "THAT THE STAFF WOULDN'T REACT AT THE VENTILATOR ALARMS WHEN THIS TYPE OF EVENT OCCURS. THEY WOULD TAKE ACTION ONLY WHEN THE MONITORING DEVICES ALARMS." FURTHER INFORMATION RECEIVED FROM THE HOSPITAL REVEALED THAT THE "BRADYCARDIA QUICKLY FIXED WITH HABIT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFANT DUAL HEATED WITH EVAQUA BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LIMITED RT235 NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention