BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATHETER MOUNT

    MDR report key: 2602043 · Received June 6, 2012

    Report

    Report Number
    9611451-2012-00372
    Event Type
    Malfunction
    Date Received
    June 6, 2012
    Date of Event
    April 23, 2012
    Report Date
    May 11, 2012
    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 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 PATIENT CONNECTOR WAS MEASURED AND CHECKED AGAINST PRODUCT SPECIFICATIONS. IT WAS FOUND TO BE WITHIN SPECIFICATION. A LOT CHECK REVEALED NO OTHER COMPLAINT OF THIS TYPE FOR LOT 111221. CONCLUSION: NO FAULT WAS FOUND ON THE COMPLAINT DEVICE AS NO DAMAGE WAS OBSERVED AND THE DEVICE WAS WITHIN SPECIFICATIONS. ALL RT021 CATHETER MOUNTS ARE PRESSURE TESTED DURING PRODUCTION, AND THOSE THAT FAIL ARE REJECTED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THERE WAS A LOOSE CONNECTION BETWEEN AN RT021 CATHETER MOUNT AND THE TRACHEOSTOMY TUBE (MADE BY (B)(4)). THIS WAS FOUND PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CATHETER MOUNT BZO BZO FISHER & PAYKEL HEALTHCARE LTD RT021 111221

    Patients

    Seq Age Sex Outcome Treatment
    1