BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INNOVA 3100

    MDR report key: 6717701 · Received July 13, 2017

    Report

    Report Number
    MW5071012
    Event Type
    Malfunction
    Date Received
    July 13, 2017
    Date of Event
    July 10, 2017
    Report Date
    July 13, 2017
    Manufacturer
    GE HEALTHCARE, LLC
    Product Code
    IZI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING A VASCULAR CATHETERIZATION PROCEDURE IN THE CATH LAB, THE TABLE THE PATIENT WAS LYING ON CRACKED. AS THE PORTION OF THE TABLE SLOWLY TILTED DOWN, THE PATIENT SLID SLOWLY ONTO THE FLOOR WITH THE PAD AND PILLOW STILL IN PLACE. THE TECH CAREFULLY LOWERED THE PATIENT INTO HER LAP. THE PATIENT WEIGHT DID NOT EXCEED THE 450 POUND TABLE LIMIT. THE PATIENT WAS UNHARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    491413 INNOVA 3100 CARDIOVASCULAR IMAGING SYSTEM - TABLE IZI GE HEALTHCARE, LLC ZJ0000MG

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR