BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATHETER MOUNT

    MDR report key: 3493299 · Received November 27, 2013

    Report

    Report Number
    9611451-2013-00954
    Event Type
    Malfunction
    Date Received
    November 27, 2013
    Date of Event
    October 28, 2013
    Report Date
    October 29, 2013
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    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 IS SOLD IN THE USA BUT HAS NO 510(K) NUMBER AS IT IS CONSIDERED A CLASS I DEVICE. METHOD: THE TWO COMPLAINT RT021 CATHETER MOUNTS WERE RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4) AND WERE VISUALLY INSPECTED. RESULTS: VISUAL INSPECTION REVEALED THAT THE TUBING CUFF OF BOTH CATHETER MOUNTS WAS SPLIT AT THE SWIVEL END. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 130614. CONCLUSION: WE ARE UNABLE TO DETERMINE THE CAUSE OF THE DAMAGE TO THE RETURNED RT021 DEVICES. 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 MOUNTS BECAME DAMAGED AFTER THEY WERE 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 REPRESENTATIVE THAT THE TUBING CUFF OF TWO RT021 CATHETER MOUNTS WAS CRACKED. THIS WAS FOUND PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620480 CATHETER MOUNT BZO BZO FISHER & PAYKEL HEALTHCARE LTD RT021 130614

    Patients

    Seq Age Sex Outcome Treatment
    1