BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED AUTOFEED CHAMBER

    MDR report key: 2856832 · Received December 4, 2012

    Report

    Report Number
    9611451-2012-00893
    Event Type
    Malfunction
    Date Received
    December 4, 2012
    Date of Event
    November 8, 2012
    Report Date
    November 8, 2012
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    K934140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). LOT NUMBERS AND DEVICE MANUFACTURER DATES: LOT 120510 - 10 MAY 2012; LOT 120726 - 26 JULY 2012; LOT 120731 - 31 JULY 2012. METHOD: THE 3 COMPLAINT MR290 CHAMBERS WERE RETURNED TO FISHER & PAYKEL HEALTHCARE FOR INSPECTION. RESULTS: ALL 3 COMPLAINT MR290 CHAMBERS HAD A BREAK IN THE FEETSET TUBE WHERE IT IS INSERTED INTO THE CHAMBER. THE SURFACE OF THE BREAK IS ROUGH AND NOT SMOOTHLY CUT. A LOT CHECK REVEALED NO OTHER COMPLAINT OF THIS TYPE FOR LOT NUMBERS 120726 AND 12073, AND ONE OTHER COMPLAINT OF THIS TYPE FOR LOT NUMBER 120510. CONCLUSION: THE DAMAGE FOUND ON THE CHAMBERS APPEARED TO HAVE BEEN CAUSED BY THE TUBE BEING PULLED, AWAY FROM THE CHAMBER, POSSIBLY DUE TO THE FEEDSET BEING CAUGHT OR UNDER TENSION. ALL CHAMBERS ARE PRESSURE TESTED BEFORE THEY LEAVE THE PRODUCTION LINE AND ANY HOLES OR LEAKS IN THE FEEDSET ARE IDENTIFIED DURING THIS PROCESS. 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 VIA A DISTRIBUTOR THAT THE FEEDSET LINE OF 3 MR290 AUTOFEED HUMIDIFICATION CHAMBERS WERE DAMAGED DURING USE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTED AUTOFEED CHAMBER AUTOFEED CHAMBER BTT FISHER & PAYKEL HEALTHCARE LTD MR290V SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1