BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIWI VACUUM WITH PALM PUMP

    MDR report key: 2763761 · Received September 19, 2012

    Report

    Report Number
    MW5027050
    Event Type
    Malfunction
    Date Received
    September 19, 2012
    Date of Event
    September 18, 2012
    Report Date
    September 19, 2012
    Manufacturer
    CLINICAL INNOVATIONS
    Product Code
    HDB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    WE HAVE A PRODUCT (KIWI VACUUM WITH PALM PUMP) THAT HAS MALFUNCTIONED OR BROKEN 6 TIMES IN THE LAST TWO WEEKS. DATE OF THIS REPORT (B)(6) 2012, TWO MORE HAVE MALFUNCTIONED. THE NUMBERS ON THE PACKAGE WERE: (B)(4) PRO, EXP DATE 2014-17, LOT: 120694, BAR CODE: (B)(4). THE PACKAGE AND VACUUM WERE COVERED WITH BLOOD SO I DID NOT KEEP. THE PRODUCT IS EITHER NOT VACUUMING/WILL NOT PUMP UP OR THE HANDLE BREAKS. THERE ARE DISPOSABLE APPLIANCES USED TO DELIVERY BABIES. DATES OF USE: (B)(6) 2012. REASON FOR USE: C-SECTION ASSIST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KIWI VACUUM WITH PALM PUMP KIWI VACUUM WITH PALM PUMP HDB CLINICAL INNOVATIONS VAC-6005 PRO 120694

    Patients

    Seq Age Sex Outcome Treatment
    1