BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATHETER MOUNT

    MDR report key: 5613952 · Received April 28, 2016

    Report

    Report Number
    9611451-2016-00182
    Event Type
    Malfunction
    Date Received
    April 28, 2016
    Date of Event
    March 14, 2016
    Report Date
    March 29, 2016
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BZO
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    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 HAS NOT BEEN RECEIVED BY FISHER & PAYKEL HEALTHCARE (B)(4) FOR EVALUATION. OUR INVESTIGATION IS BASED ON INFORMATION PROVIDED BY THE CUSTOMER. RESULTS: FURTHER INFORMATION ELICITED FROM THE CUSTOMER REVEALED THAT THE NATURE OF THE DAMAGE WAS A "SPREAD CIRCUIT" AND THAT THIS DAMAGE CAUSED A LEAK IN THE BREATHING SYSTEM. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT 150817. CONCLUSION: BASED ON THE INFORMATION SUPPLIED, IT APPEARS THAT THE TUBING WAS SPLIT, MOST LIKELY AT THE CUFF. PREVIOUS INVESTIGATIONS INTO THIS TYPE OF FAILURE HAVE SHOWN THAT THE TUBING CUFF CAN SPLIT AS A RESULT OF ENVIRONMENTAL STRESS CRACKING. ALL RT021 CATHER MOUNTS ARE PRESSURE TESTED PRIOR TO RELEASE FOR DISTRIBUTION. ANY CATHETER MOUNT WITH A SPLIT TUBE WOULD HAVE FAILED THE PRESSURE TEST AND BEEN REJECTED FROM THE PRODUCTION LINE. 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 THAT AN RT021 CATHETER MOUNT HAD A "HOLE IN THE ELBOW". THE PROBLEM WAS SOLVED BY REPLACING THE RT021. THIS WAS FOUND 15 MINUTES AFTER CONNECTING THE RT021 TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272413 CATHETER MOUNT BZO BZO FISHER & PAYKEL HEALTHCARE LTD RT021 150817

    Patients

    Seq Age Sex Outcome Treatment
    1