BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIWI

    MDR report key: 5073990 · Received September 14, 2015

    Report

    Report Number
    5073990
    Event Type
    Malfunction
    Date Received
    September 14, 2015
    Date of Event
    April 8, 2015
    Report Date
    September 1, 2015
    Manufacturer
    CLINICAL INNOVATIONS, LLC
    Product Code
    HDB
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE KIWI VACUUM USED TO ASSIST WITH A VAGINAL DELIVERY WOULD NOT RELEASE THE SUCTION OFF BABY'S HEAD FOLLOWING DELIVERY. THE TUBING HAD TO BE CUT TO RELEASE FROM THE HEAD OF THE BABY. THERE WAS NO HARM TO THE BABY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    607363 KIWI EXTRACTOR FETAL VACUUM HDB CLINICAL INNOVATIONS, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1