BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT INSPIRATORY HEATED BREATHING CIRCUIT

    MDR report key: 3083784 · Received April 29, 2013

    Report

    Report Number
    9611451-2013-00330
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    April 4, 2013
    Report Date
    April 4, 2013
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BTT
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT RT212 ADULT INSPIRATORY HEATED 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 RT212 ADULT INSPIRATORY HEATED BREATHING CIRCUIT IS NOT SOLD IN THE USA BUT IT IS SIMILAR TO A PRODUCT WHICH IS SOLD IN THE USA. THE 510(K) FOR THAT PRODUCT IS K983112. METHOD: THE COMPLAINT RT212 ADULT BREATHING CIRCUIT WAS RETURNED TO FPH IN (B)(4) AND WAS VISUALLY INSPECTED. RESULTS: VISUAL INSPECTION REVEALED A HOLE ABOUT 2.5CM FROM THE CONNECTOR OF THE DRYLINE TUBE. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 120316. CONCLUSION: IT WAS IDENTIFIED THAT DAMAGE TO THE RT212 DRYLINE WAS CAUSED BY A FAULTY CORRUGATOR BLOCK THAT WAS USED DURING THE DRYLINE MANUFACTURING PROCESS. THE FAULTY CORRUGATOR BLOCK WAS REPLACED LAST YEAR; HOWEVER, THE SUBJECT DRYLINE TUBE WAS MANUFACTURED PRIOR TO THE REPLACEMENT OF THAT FAULTY BLOCK. DURING THE PRODUCTION OF THE DRYLINE TUBES, A PRESSURE TEST IS PERFORMED (B)(4) AND THOSE THAT FAIL ARE SET ASIDE FOR FURTHER INSPECTION. THE USER INSTRUCTIONS THAT ACCOMPANY THE RT212 ADULT INSPIRATORY-HEATED BREATHING CIRCUIT STATE THE FOLLOWING: "PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM AND CHECK FOR OCCLUSIONS BEFORE CONNECTING TO A PATIENT." "SET APPROPRIATE VENTILATOR ALARMS." (B)(4).

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT THERE WAS A HOLE IN ONE OF THE LIMBS OF AN RT212 ADULT INSPIRATORY HEATED BREATHING CIRCUIT. THIS WAS OBSERVED BEFORE USE ON A PATIENT.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT THERE WAS A HOLE IN ONE OF THE LIMBS OF AN RT212 ADULT INSPIRATORY HEATED BREATHING CIRCUIT. THIS WAS OBSERVED BEFORE USE ON A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184080 ADULT INSPIRATORY HEATED BREATHING CIRCUIT BTT BTT FISHER & PAYKEL HEALTHCARE LIMITED RT212 120316

    Patients

    Seq Age Sex Outcome Treatment
    1