BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATHETER MOUNT

    MDR report key: 2379967 · Received December 16, 2011

    Report

    Report Number
    9611451-2011-00792
    Event Type
    Malfunction
    Date Received
    December 16, 2011
    Date of Event
    November 12, 2011
    Report Date
    November 18, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BZO
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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: ONLY ONE COMPLAINT RT021 CATHETER MOUNT WAS RETURNED TO FISHER & PAYKEL HEALTHCARE (B)(4) AND VISUALLY INSPECTED. RESULTS: VISUAL INSPECTION REVEALED THAT NO DAMAGE WAS FOUND ON THE CONNECTOR. THE INNER DIAMETER OF THE CONNECTOR WAS CHECKED AGAINST PRODUCT SPECIFICATIONS AND FOUND TO BE OUT OF SPECIFICATION. A LOT CHECK REVEALED NO OTHER COMPLAINT OF THIS TYPE FOR LOT 111006. CONCLUSION: WE ARE UNABLE TO DETERMINE WHETHER THE CONNECTOR WAS MANUFACTURED OUT OF SPECIFICATION OR IF THE CONNECTOR WAS STRETCHED DUE TO USE. ALL RT021 CATHETER MOUNTS ARE PRESSURE TESTED DURING PRODUCTION, AND THOSE THAT FAIL ARE REJECTED.

    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. WE ARE CURRENTLY ENDEAVOURING TO OBTAIN MORE INFORMATION ON THE COMPLAINT DEVICE AND THE DEVICE RETURN. WE WILL PROVIDE A FOLLOW-UP REPORT UPON RECEIPT OF THE COMPLAINT DEVICE AND COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT AN RT021 CATHETER MOUNT WAS NO ATTACHING SECURELY TO THE BREATHING TUBE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT TWO RT021 CATHETER MOUNTS WERE NOT ATTACHING SECURELY TO THE BREATHING TUBE DURING PATIENT USE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CATHETER MOUNT BZO BZO FISHER & PAYKEL HEALTHCARE LTD RT021 111006

    Patients

    Seq Age Sex Outcome Treatment
    1