BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED AUTOFEED CHAMBER

    MDR report key: 2862002 · Received December 7, 2012

    Report

    Report Number
    9611451-2012-00897
    Event Type
    Malfunction
    Date Received
    December 7, 2012
    Date of Event
    November 7, 2012
    Report Date
    November 9, 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). METHOD: THE COMPLAINT MR290 CHAMBER WAS RETURNED TO FISHER & PAYKEL HEALTHCARE FOR INSPECTION AND CONNECTED TO A WATER BAG TO CHECK FOR LEAKS. RESULTS: UPON CONNECTING TO THE WATERBAG, A DROP OF WATER BEGAN TO BUILD AT THE CONNECTION BETWEEN THE FEEDSET TUBE AND THE WATERBAG SPIKE. A SUFFICIENT AMOUNT OF GLUE WAS FOUND AT THE SPIKE AND FEEDSET TUBE CONNECTION. A LOT CHECK REVEALED NO OTHER COMPLAINT OF THIS TYPE FOR LOT NUMBER 120501. CONCLUSION: A SUFFICIENT AMOUNT OF GLUE WAS APPLIED TO THE SPIKE TUBING CONNECTIONS, BUT THE GLUE WAS FOUND TO BE PARTLY BONDING. WE WERE UNABLE TO DETERMINE THE CAUSE OF THE FAILURE. ALL CHAMBERS ARE PRESSURE TESTED BEFORE THEY LEAVE THE PRODUCTION LINE AND ANY LEAKS IN THE FEEDSET ARE IDENTIFIED DURING THIS PROCESS. THIS PRODUCT WOULD HAVE FAILED THE FINAL PRESSURE TEST IF IT WAS IN A BROKEN STATE DURING TESTING. 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 AN MR290 AUTOFEED HUMIDIFICATION CHAMBER WAS 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 120501

    Patients

    Seq Age Sex Outcome Treatment
    1