BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KIWI COMPLETE VACUUM DELIVERY SYSTEM WITH PALMPUMP

    MDR report key: 2390194 · Received December 21, 2011

    Report

    Report Number
    MW5023589
    Event Type
    Injury
    Date Received
    December 21, 2011
    Date of Event
    December 9, 2011
    Report Date
    December 21, 2011
    Manufacturer
    CLINICAL INNOVATIONS, INC
    Product Code
    HDB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    USING VACUUM TO DELIVER BABY WITH FETAL BRADYCARDIA; VACUUM WOULD NOT PUMP UP, SECOND VACUUM OBTAINED, INFANT DELIVERED WITHOUT DIFFICULTY; (B)(4) COMPLETE VACUUM DELIVERY SYS WITH PALM PUMP, LOT # 110736; (B)(4), EXP DATE 2013-08, THE ACTUAL VACUUM WAS TOO CONTAMINATED TO SAVE. NO ADVERSE EFFECTS TO MOTHER OR INFANT; SECOND VACUUM OPERATED APPROPRIATELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KIWI COMPLETE VACUUM DELIVERY SYSTEM WITH PALMPUMP VAC 6000 HDB CLINICAL INNOVATIONS, INC VAC-6000S PRO 110736

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Life Threatening