BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INNOVA 3100-IQ

    MDR report key: 3810805 · Received March 21, 2014

    Report

    Report Number
    9611343-2014-00059
    Event Type
    Malfunction
    Date Received
    March 21, 2014
    Date of Event
    February 19, 2014
    Report Date
    February 19, 2014
    Manufacturer
    GE MEDICAL SYSTEMS SCS
    Product Code
    OWB
    PMA / PMN Number
    K092004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    GE HEALTHCARE'S INVESTIGATION IS ONGOING. A F/U REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SURGICAL LAMP WITHIN A CATH LAB OF AN INNOVA 3100-IQ VASCULAR SYSTEM, AND ATTACHED TO A BOOM FROM THE CEILING, FELL ON THE FLOOR CLOSE TO A NURSE WHO WAS PREPARING FOR AN EXAM. NO INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    169368 INNOVA 3100-IQ INTERVENTIONAL FLUOROSCOPIC X-RAY OWB GE MEDICAL SYSTEMS SCS

    Patients

    Seq Age Sex Outcome Treatment
    1