BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIWI WITH PALM PUMP

    MDR report key: 3861075 · Received May 16, 2014

    Report

    Report Number
    3861075
    Event Type
    Malfunction
    Date Received
    May 16, 2014
    Date of Event
    May 5, 2014
    Report Date
    May 16, 2014
    Manufacturer
    CLINICAL INNOVATIONS, INC.
    Product Code
    HDB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING C-SECTION DELIVERY, THE PHYSICIAN REQUESTED KIWI VACUUM. THERE WERE ISSUES WITH THREE DIFFERENT KIWI SETS. THE FIRST KIWI APPEARED TO HAVE INADEQUATE SUCTION INTENSITY. THE SECOND KIWI APPEARED TO HAVE BEEN DEFECTIVE (DARK PART VISIBLE ON HANDLE). THE THIRD KIWI APPEARED DEFECTIVE AND SUCTION WAS INADEQUATE. THE FOURTH KIWI WAS OPENED BUT NOT USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293766 KIWI WITH PALM PUMP EXTRACTOR, VACUUM, FETAL HDB CLINICAL INNOVATIONS, INC. * 130524, 130622, 131158

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR NO OTHER THERAPIES