BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIWI VACUUM ASSISTED DELIVERY DEVICE

    MDR report key: 4949017 · Received July 27, 2015

    Report

    Report Number
    1722684-2015-00005
    Event Type
    Malfunction
    Date Received
    July 27, 2015
    Date of Event
    May 31, 2013
    Report Date
    July 22, 2015
    Manufacturer
    CLINICAL INNOVATIONS, LLC
    Product Code
    HDB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CLINICAL INNOVATIONS BECAME AWARE OF THIS INCIDENT ON (B)(6) 2015. NO REPORT FROM THE HOSP WAS RECEIVED BY CLINICAL INNOVATIONS, AND A MAUDE DATABASE SEARCH DID NOT REVEAL A REPORT FROM THE HOSP. THE DEVICE IN QUESTION WAS NOT RETURNED TO US FOR EVALUATION, AND NEITHER THE PART OR LOT NUMBER WERE REPORTED TO US. AS SUCH, WE CANNOT DETERMINE THE FUNCTIONAL STATE OF THE DEVICE IN QUESTION. A REVIEW OF INFORMATION PRESENTED INDICATED THAT, IF THE DEVICE POPPED-OFF, THE DEVICE WAS ABLE TO ACHIEVE SUCTION. IT CANNOT BE DETERMINED, HOWEVER, WHETHER THE PLACEMENT OF THE DEVICE WAS CORRECT, OR IF OTHER CONDITIONS WERE PRESENT THAT WOULD HAVE INTERFERED W/PROPER PLACEMENT AND/OR ABILITY TO ACHIEVE APPROPRIATE SUCTION. THE EXACT ROOT CAUSE OF THIS INCIDENT CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    ON (B)(6) 2015, CLINICAL INNOVATIONS WAS MADE AWARE VIA LAWSUIT, OF AN EVENT W/A KIWI VACUUM ASSISTED DELIVERY DEVICE THAT OCCURRED PM, (B)(6) 2013. THE REPORT INDICATES THAT, DURING A CESAREAN DELIVERY, A KIWI VACUUM ASSISTED DELIVERY DEVICE POPPED OFF THE BABY'S HEAD THREE TIMES. THE REPORT INDICATED THAT A DELAY IN THE DELIVERY OCCURRED AND THAT THE PHYSICIAN FAILED TO DELIVER THE BABY W/IN 3 MINUTES OF THE INCISION. THE REPORT CLAIMS THAT THE BABY SUFFERED PERMANENT AND IRREVERSIBLE NEUROLOGICAL INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    487751 KIWI VACUUM ASSISTED DELIVERY DEVICE KIWI VACUUM ASSISTED DELIVERY DEVICE HDB CLINICAL INNOVATIONS, LLC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK