BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEX CUP

    MDR report key: 4173381 · Received September 28, 2014

    Report

    Report Number
    4173381
    Event Type
    Malfunction
    Date Received
    September 28, 2014
    Date of Event
    April 28, 2014
    Report Date
    September 28, 2014
    Manufacturer
    UTAH MEDICAL PRODUCTS, INC
    Product Code
    HDB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE CLINICIAN ATTEMPTED TO ATTACH A MITTYVAC DEVICE TO THE HANDLE, BUT THE SUCTION COULD NOT BE MAINTAINED. TWO OUT OF THREE MACHINES DID NOT WORK AND ALL 3 MACHINES WERE FROM THE SAME LOT NUMBER 1133087. THIS DID NOT IMPACT PATIENT CARE.======================MANUFACTURER RESPONSE FOR OB VACUUM DELIVERY SYSTEM, (BRAND NOT PROVIDED) (PER SITE REPORTER).======================FACTS ARE STILL MISSING, BUT THE DEVICES FROM THIS LOT WERE PULLED FROM USE AT THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    604009 FLEX CUP EXTRACTOR, VACUUM, FETAL HDB UTAH MEDICAL PRODUCTS, INC * 1133087

    Patients

    Seq Age Sex Outcome Treatment
    1 * WAS NOT REPORTED TO BE THE PROBLEM.| THE DEVICE CONNECTS TO A HANDLE, BUT THE HANDLE