BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATHETER MOUNT

    MDR report key: 4556087 · Received March 1, 2015

    Report

    Report Number
    9611451-2015-00110
    Event Type
    Malfunction
    Date Received
    March 1, 2015
    Date of Event
    February 9, 2015
    Report Date
    February 13, 2015
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BZO
    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 COMPLAINT RT021 CATHETER MOUNT WAS RETURNED TO FISHER & PAYKEL HEALTHCARE IN NEW ZEALAND FOR EVALUATION AND WAS VISUALLY INSPECTED. RESULTS: VISUAL INSPECTION REVEALED THAT THE RT021 HAD BEEN PULLED AND THE TUBING WAS TORN. A LOT CHECK REVEALED NO OTHER SIMILAR COMPLAINTS FOR LOT NUMBER 140702. CONCLUSION: WE ARE UNABLE TO DETERMINE THE CAUSE OF THE DAMAGE TO THE RETURNED RT021. ALL RT021 CATHETER MOUNTS ARE PRESSURE TESTED AND VISUALLY INSPECTED PRIOR TO BEING RELEASED FOR DISTRIBUTION. ANY CATHETER MOUNT WITH A TORN TUBE WOULD HAVE FAILED THE PRESSURE TEST. THE CUSTOMER HAS CONFIRMED THAT THE SUBJECT RT021 BECAME DAMAGED AFTER THEY REMOVED IT FROM THE TEST LUNG AFTER THE VENTILATOR LEAK TEST, WHICH INDICATES THAT THE RT021 BECAME DAMAGED DURING HANDLING.

    Description of Event or Problem · 1

    A MEDICAL CENTER IN (B)(6) REPORTED VIA A FISHER & PAYKEL HEALTHCARE FIELD REPRESENTATIVE THAT A RT021 CATHETER MOUNT TUBE WAS DAMAGED. THIS WAS OBSERVED PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    141466 CATHETER MOUNT BZO BZO FISHER & PAYKEL HEALTHCARE LIMITED RT021 140702

    Patients

    Seq Age Sex Outcome Treatment
    1