BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KIWI COMPLETE VACUUM DELIVERY SYSTEM

    MDR report key: 8143739 · Received December 7, 2018

    Report

    Report Number
    1722684-2018-00016
    Event Type
    Injury
    Date Received
    December 7, 2018
    Date of Event
    June 24, 2018
    Report Date
    December 6, 2018
    Manufacturer
    CLINICAL INNOVATIONS, LLC
    Product Code
    HDB
    UDI-DI
    00814247020635
    PMA / PMN Number
    K981260
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TC
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ON NOVEMBER 29, 2018, CLINICAL INNOVATIONS WAS INFORMED BY THE USER FACILITY THAT A SERIOUS INJURY HAD OCCURRED THAT WAS NOT PREVIOUSLY COMMUNICATED WHEN THE COMPLAINT WAS FIRST RECEIVED. THE PHYSICIAN INVOLVED IN THE DELIVERY STATED THAT THE BABY SUFFERED "SEVERE HYPOXIC-ISCHEMIC ENCEPHALOPATHY" DUE TO THE DEVICE NOT WORKING PROPERLY. THE PHYSICIAN USED 4 DIFFERENT DEVICES. NO DEVICES WILL BE RETURNED, SO WE CANNOT FURTHER INVESTIGATE THE ROOT-CAUSE OF THIS EVENT. THERE ARE NO ADDITIONAL COMPLAINTS ASSOCIATED WITH LOT 180412 TO DATE. WE HAVE REACHED OUT TO OBTAIN ADDITIONAL INFORMATION ON SEVERAL OCCASIONS AND HAVE BEEN TOLD THIS IS ALL THE INFORMATION AVAILABLE.

    Description of Event or Problem · 1

    WE ARE EXPERIENCING DIFFICULTIES WITH OUR VACUUM DELIVERIES IN THE PAST FEW DAYS. IT SEEMS THAT KIWI OMNICUP IS NOT PROVIDING ENOUGH VACUUM TO APPLY SUFFICIENT PRESSURE IN ORDER TO FACILITATE A SUCCESSFUL DELIVERY (WITH REPEATED POP-OFF ISSUE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    981871 KIWI COMPLETE VACUUM DELIVERY SYSTEM FETAL VACUUM EXTRACTOR HDB CLINICAL INNOVATIONS, LLC VAC-6000ME 180412 00814247020635

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DA Required Intervention