BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 1000012 · Received December 19, 2007

    Report

    Report Number
    9616240-2007-00118
    Event Type
    Malfunction
    Date Received
    December 19, 2007
    Manufacturer
    *
    Product Code
    KDI
    PMA / PMN Number
    K001156
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Additional Manufacturer Narrative · 1

    IMPROVEMENTS TO INCREASE THE ROBUSTNESS OF THE HYDRAULIC CONNECTIONS HAVE BEEN DESIGNED AND VALIDATED AND ARE CURRENTLY BEING INTRODUCED IN THE FIELD TO AVOID THE OCCURRENCE OF TUBING DISCONNECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * * KDI * * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *