BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRE¿ PULMONARY

    MDR report key: 7464191 · Received April 26, 2018

    Report

    Report Number
    3005099803-2018-01402
    Event Type
    Malfunction
    Date Received
    April 26, 2018
    Report Date
    March 31, 2018
    Product Code
    KTI
    PMA / PMN Number
    K023337
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOR THE 4 EVENTS REPORTED UNDER EXEMPTION NUMBER E2012010, 3 COMPLAINT DEVICES WERE RETURNED, AND 1 COMPLAINT DEVICE WAS DISPOSED. 1 EVENT WAS FOUND TO HAVE A ROOT CAUSE OF OPERATIONAL CONTEXT, AND 1 EVENT WAS FOUND TO HAVE A ROOT CAUSE OF HANDLING. INVESTIGATION IS STILL IN PLACE FOR 1 EVENT.

    Description of Event or Problem · 1

    THE MANUFACTURER REPORT IS BEING SENT AS A REQUIREMENT UNDER SUMMARY REPORTING EXEMPTION APPROVAL NUMBER E2012010 FOR PRODUCT CODE KTI. THIS REPORT COVERS 4 REPORTED EVENTS OF BALLOONS HOLE/LEAK/TEARS. OF THE EVENTS, 2 PATIENTS WERE FEMALE AND 1 WAS MALE. THE KNOWN PATIENTS' AGES RANGED FROM 55 YEARS TO 68 YEARS. THE KNOWN PATIENTS' WEIGHTS RANGED FROM 43 KG TO 70 KG. ALL OTHER DEMOGRAPHIC INFORMATION IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307551 CRE¿ PULMONARY BRONCHOSCOPE ACCESSORY KTI M00550350

    Patients

    Seq Age Sex Outcome Treatment
    1