BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIWI VACUUM ASSISTED FETAL DELIVERY

    MDR report key: 3599235 · Received January 23, 2014

    Report

    Report Number
    MW5034005
    Event Type
    Malfunction
    Date Received
    January 23, 2014
    Date of Event
    January 9, 2014
    Report Date
    January 20, 2014
    Manufacturer
    CLINICAL INNOVATIONS, INC.
    Product Code
    HDB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    VACUUM ASSISTED DELIVERY. KIWI VACUUM (LOT # 130524) AUDIBLY LOSES SUCTION. SECOND VACUUM PLACED WITH SAME LOT NUMBER. THIS VACUUM ALSO LOSES SUCTION. PT CONTINUES TO PUSH. THIRD VACUUM PLACED (LOT # 131107). VACUUM PLACED AND INFANT HEAD DELIVERED. INFANT HANDED TO AWAITING HIGH RISK TEAM. APGAR'S 7/8, TRANSFER TO IMCN FOR CHORIO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55023 KIWI VACUUM ASSISTED FETAL DELIVERY KIWI VACUUM ASSISTED FETAL DELIVERY HDB CLINICAL INNOVATIONS, INC. 130524
    55024 KIWI VACUUM ASSISTED FETAL DELIVERY KIWI VACUUM ASSISTED FETAL DELIVERY HDB CLINICAL INNOVATIONS, INC. 130524
    55025 KIWI VACUUM ASSISTED FETAL DELIVERY KIWI VACUUM ASSISTED FETAL DELIVERY HDB CLINICAL INNOVATIONS, INC. 131107

    Patients

    Seq Age Sex Outcome Treatment
    1 Other