BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIWI PROCUP VACUUM DELIVERY SYSTEM

    MDR report key: 5646267 · Received May 6, 2016

    Report

    Report Number
    MW5062188
    Event Type
    Malfunction
    Date Received
    May 6, 2016
    Date of Event
    April 28, 2016
    Report Date
    May 6, 2016
    Manufacturer
    KENTEC MEDICAL INC
    Product Code
    HDB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    KIWI PROCUP VACUUM DELIVERY SYSTEM MALFUNCTIONED (FELL APART) DURING AN EMERGENT CESAREAN DELIVERY CASE. WHEN THE VACUUM WAS PLACED ON THE BABY'S HEAD AND THE HANDLE WAS DEPRESSED, THE UNIT MALFUNCTIONED AND FELL APART. MULTIPLE SIMILAR SITUATIONS HAVE OCCURRED WITH THIS DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293263 KIWI PROCUP VACUUM DELIVERY SYSTEM VACUUM CUP HDB KENTEC MEDICAL INC VAC-6000S UNSURE

    Patients

    Seq Age Sex Outcome Treatment
    1