BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIWI PROCUP VACCUUM DELIVERY SYSTEM

    MDR report key: 2971962 · Received February 7, 2013

    Report

    Report Number
    2971962
    Event Type
    Malfunction
    Date Received
    February 7, 2013
    Date of Event
    February 6, 2012
    Report Date
    February 7, 2013
    Manufacturer
    CLINICAL INNOVATIONS, INC.
    Product Code
    HDB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DR REQUESTED VACUUM FOR VAGINAL DELIVERY. VACUUM WAS OPENED, APPLIED TO FETAL HEAD. DR STATED THAT THE VACUUM DID NOT HAVE ANY SUCTION WHEN USING THE PUMP. DISCARDED FAULTY VACUUM AND OPENED ANOTHER AND APPLIED, FACILITATING DELIVERY OF INFANT.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?SAFE DELIVERY OF INFANT IN LABOR AND DELIVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53180 KIWI PROCUP VACCUUM DELIVERY SYSTEM EXTRACTOR, VACUUM HDB CLINICAL INNOVATIONS, INC. * 120871

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR