BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT VENTILATOR DUAL HEATED CIRCUIT KIT

    MDR report key: 6844205 · Received September 6, 2017

    Report

    Report Number
    9611451-2017-00828
    Event Type
    Malfunction
    Date Received
    September 6, 2017
    Date of Event
    August 8, 2017
    Report Date
    August 9, 2017
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BZE
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE 950A81 ADULT VENTILATOR DUAL HEATED CIRCUIT KIT 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 K122432. METHOD: FOUR COMPLAINT 950A81 CIRCUITS WERE RETURNED TO FPH IN (B)(6) FOR INVESTIGATION. THE CIRCUITS WERE VISUALLY INSPECTED. RESULT: VISUAL INSPECTION REVEALED THAT TWO CIRCUITS HAD DRYLINE ELBOWS THAT WERE CRACKED OFF FROM THE DRYLINE TUBES AND THAT THE BROKEN ENDS OF THE DRYLINE ELBOWS HAD HAIRLINE CRACKS. THE THIRD CIRCUIT HAD A DRYLINE ELBOW THAT WAS CRACKED INSIDE THE CUFF OF THE DRYLINE TUBE. THE FOURTH CIRCUIT HAD A DRYLINE ELBOW THAT WAS NOT DAMAGED. CONCLUSION: THE NATURE OF THE CRACKING INDICATE THAT THE DRYLINE ELBOWS CAME INTO CONTACT WITH A SOLUTION CONTAINING ALCOHOL WHICH HAS RESULTED IN ENVIRONMENTAL STRESS CRACKING OF THE DRYLINE ELBOW. FPH PRODUCT DEVELOPMENT ENGINEERS ARE IN THE PROCESS OF IMPROVING THE DRYLINE ELBOW BY MODIFYING THE DESIGN AND CHANGING THE MATERIAL. OUR USER INSTRUCTIONS THAT ACCOMPANY THE 950A81 ADULT VENTILATOR DUAL HEATED CIRCUIT KITS STATE THE FOLLOWING: DO NOT CLEAN OR STERILIZE THIS PRODUCT. AVOID CONTACT WITH CHEMICALS, CLEANING AGENTS OR HAND SANITIZERS.

    Additional Manufacturer Narrative · 1

    (B)(4). THE 950A81 ADULT VENTILATOR DUAL HEATED CIRCUIT KIT 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 K122432. THE COMPLAINT 950A81 ADULT VENTILATOR DUAL HEATED CIRCUIT KITS ARE CURRENTLY EN ROUTE TO FPH IN NEW ZEALAND FOR EVALUATION. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT THE DRYLINE ELBOWS OF TWO 950A81 ADULT VENTILATOR DUAL HEATED CIRCUIT KITS HAD BROKEN. THE ELBOW OF THE FIRST DRYLINE BROKE AFTER ONE DAY OF USE AND THE ELBOW OF THE SECOND DRYLINE BROKE DURING SETUP. THERE WAS NO PATIENT CONSEQUENCE.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT THE DRYLINE ELBOWS OF TWO 950A81 ADULT VENTILATOR DUAL HEATED CIRCUIT KITS HAD BROKEN. THE ELBOW OF THE FIRST DRYLINE BROKE AFTER ONE DAY OF USE AND THE ELBOW OF THE SECOND DRYLINE BROKE DURING SETUP. THERE WAS NO PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    624597 ADULT VENTILATOR DUAL HEATED CIRCUIT KIT BZE BZE FISHER & PAYKEL HEALTHCARE LTD 950A81 2100176382

    Patients

    Seq Age Sex Outcome Treatment
    1