BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATHETER MOUNT

    MDR report key: 1005599 · Received March 5, 2008

    Report

    Report Number
    9611451-2008-00090
    Event Type
    Malfunction
    Date Received
    March 5, 2008
    Date of Event
    January 13, 2008
    Report Date
    January 13, 2008
    Manufacturer
    FISHER & PAYKEL HEALTHCARE, LTD.
    Product Code
    BZO
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS A MALFUNCTION THAT HAS BEEN REPORTED TO FISHER & PAYKEL HEALTHCARE BY A DISTRIBUTOR. THE PRODUCT IS ALSO SOLD IN THE USA. SEVEN WHITE CONNECTORS, WITH LOT NUMBER 070412, WERE REPORTED TO HAVE LOOSE CONNECTIONS. ONLY ONE WAS RETURNED FOR INVESTIGATION. THE EVALUATION WAS DONE USING THE RETURNED DEVICE AND THE PHOTOGRAPH PROVIDED BY THE DISTRIBUTOR. RESULTS: THE DIMENSIONS OF THE CONNECTOR WERE CHECKED AGAINST THE DRAWING AND FOUND TO BE DEFECTIVE DUE TO MOULDING ERROR. CONCLUSIONS: A MOULDING ERROR SLIGHTLY REDUCED THE SIZE OF THE CONNECTOR, PREVENTING ADEQUATE BONDING TO THE TUBE.

    Description of Event or Problem · 1

    A HOSPITAL REPORTED TO OUR DISTRIBUTOR THAT THE WHITE CONNECTOR OF THE CATHETER MOUNT OF THE BREATHING CIRCUIT WAS LOOSELY CONNECTED. THIS WAS FOUND PRIOR TO USE. NO PT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CATHETER MOUNT BZO FISHER & PAYKEL HEALTHCARE, LTD. RT021 070412

    Patients

    Seq Age Sex Outcome Treatment
    1