BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED AUTOFEED CHAMBER

    MDR report key: 2908224 · Received January 10, 2013

    Report

    Report Number
    9611451-2013-00024
    Event Type
    Malfunction
    Date Received
    January 10, 2013
    Date of Event
    December 5, 2012
    Report Date
    December 13, 2012
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    K934140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT DEVICE IS EN ROUTE TO FISHER & PAYKEL HEALTHCARE IN (B)(4) FOR EVALUATION. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT MR290 AUTOFEED HUMIDIFICATION CHAMBER WAS RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4) WHERE IT WAS VISUALLY INSPECTED FOR THE REPORTED DAMAGE. RESULTS: VISUAL INSPECTION REVEALED THAT THE FEEDSET TUBING WAS SEPARATED FROM THE BAG SPIKE. SUFFICIENT GLUE WAS PRESENT AROUND THE SPIKE TUBING CONNECTION; HOWEVER, THE GLUE HAD NO BONDED PROPERLY. A LOT CHECK REVEALED ONE OTHER COMPLAINT OF THIS NATURE FOR LOT NUMBER 120419. CONCLUSION: IT WAS IDENTIFIED THAT THE SEPARATION OF THE SPIKE AND FEEDSET TUBE WAS DUE TO THE FAILURE OF THE GLUE BOND. WE WERE UNABLE TO DETERMINE THE CAUSE FOR THIS. ALL CHAMBERS ARE PRESSURE TESTED BEFORE LEAVING THE PRODUCTION LINE AND ANY HOLES OR LEAKS IN THE FEEDSET ARE IDENTIFIED DURING THIS PROCESS. THIS SUGGESTS THAT THE FAILURE OF THE BOND DEVELOPED POST PRODUCTION. THE USER INSTRUCTIONS WHICH ACCOMPANY THE MR290 CHAMBER STATE THE FOLLOWING: "SET APPROPRIATE VENTILATOR ALARM." "PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM AND CHECK FOR OCCLUSIONS BEFORE CONNECTING TO A PATIENT." (B)(4).

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) REPRESENTATIVE THAT THE WATER FEED SET TUBE FELL OFF THE BAG SPIKE OF AN MR290 AUTOFEED HUMIDIFICATION CHAMBER. THIS WAS FOUND AFTER ONE WEEK OF USE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) REPRESENTATIVE THAT THE WATER FEED SET TUBE FELL OFF THE BAG SPIKE OF AN MR290 AUTOFEED HUMIDIFICATION CHAMBER. THIS WAS FOUND AFTER ONE WEEK OF USE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    15637 VENTED AUTOFEED CHAMBER AUTOFEED CHAMBER BTT FISHER & PAYKEL HEALTHCARE LTD MR290V 120419

    Patients

    Seq Age Sex Outcome Treatment
    1