BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATHETER MOUNT`

    MDR report key: 3635548 · Received February 19, 2014

    Report

    Report Number
    9611451-2014-00140
    Event Type
    Malfunction
    Date Received
    February 19, 2014
    Date of Event
    January 15, 2014
    Report Date
    January 21, 2014
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BZO
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: THE COMPLAINT RT021 CATHETER MOUNT WAS RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4) AND WAS VISUALLY INSPECTED. RESULTS: VISUAL INSPECTION REVEALED THAT THE TUBING CUFF OF THE CATHETER MOUNT WAS SPLIT AT THE CONNECTOR END. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 130924. CONCLUSION: WE ARE UNABLE TO DETERMINE THE CAUSE OF THE DAMAGE TO THE RETURNED RT02. ALL RT021 CATHETER MOUNTS ARE PRESSURE TESTED AND VISUALLY INSPECTED PRIOR TO BEING RELEASED FOR DISTRIBUTION. ANY CATHETER MOUNT WITH A SPLIT TUBE WOULD HAVE FAILED THE PRESSURE TEST. THIS SUGGESTS THAT THE RETURNED CATHETER MOUNT BECAME DAMAGED AFTER IT WAS RELEASED FOR DISTRIBUTION. OUR USER INSTRUCTIONS THAT ACCOMPANY THE RT021 CATHETER MOUNT STATE THE FOLLOWING: - "CHECK ALL CONNECTIONS ARE TIGHT BEFORE USE." - "PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM AND CHECK FOR OCCLUSIONS BEFORE CONNECTING TO A PATIENT."

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A FISHER & PAYKEL HEALTHCARE FIELD REPRESENTATIVE THAT AN RT021 CATHETER MOUNT TUBING CUFF WAS TORN. THIS WAS FOUND PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105346 CATHETER MOUNT` BZO BZO FISHER & PAYKEL HEALTHCARE LIMITED RT021 130924

    Patients

    Seq Age Sex Outcome Treatment
    1