BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATHETER MOUNT

    MDR report key: 3380214 · Received October 1, 2013

    Report

    Report Number
    9611451-2013-00743
    Event Type
    Malfunction
    Date Received
    October 1, 2013
    Date of Event
    August 27, 2013
    Report Date
    September 2, 2013
    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

    (B)(4). THE RT021 CATHETER MOUNT IS SOLD IN THE USA BUT HAS NO 510(K) NUMBER AS IT IS CONSIDERED A CLASS I DEVICE. METHOD: THE COMPLAINT RT021 CATHETER MOUNT WAS RETURNED TO FPH IN (B)(4) AND WAS VISUALLY INSPECTED. RESULTS: VISUAL INSPECTION REVEALED THAT THE TUBING CUFF AT THE SWIVEL END OF THE SUBJECT CATHETER MOUNT WAS SPLIT, CONFIRMING THE REPORTED FAULT. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 130416. CONCLUSION: WE WERE UNABLE TO DETERMINE THE ROOT CAUSE OF THE REPORTED FAULT. ALL CATHETER MOUNTS ARE PRESSURE TESTED PRIOR TO BEING RELEASED FOR DISTRIBUTION. ANY CATHETER MOUNT WITH DAMAGED TUBING WOULD HAVE FAILED THE PRESSURE TEST. THIS SUGGESTS THAT THE TUBING OF THE SUBJECT RT021 CATHETER MOUNT BECAME DAMAGED AFTER IT WAS RELEASED FOR DISTRIBUTION. THE 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 TO A FISHER & PAYKEL HEALTHCARE (FPH) THAT THE TUBE NEAR THE ELBOW OF AN RT021 CATHETER MOUNT WAS TORN. THIS WAS OBSERVED BEFORE USE ON A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    495213 CATHETER MOUNT BZO BZO FISHER & PAYKEL HEALTHCARE LIMITED RT021 130416

    Patients

    Seq Age Sex Outcome Treatment
    1