BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INNOVA 4100

    MDR report key: 3181657 · Received June 14, 2013

    Report

    Report Number
    9611343-2013-00019
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Date of Event
    May 15, 2013
    Report Date
    May 15, 2013
    Manufacturer
    GE MEDICAL SYSTEMS SCS
    Product Code
    OWB
    PMA / PMN Number
    K052412
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    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 FUMES AND A STRONG ODOR OF BATTERY ACID FROM INSIDE THE INNOVA CATHLAB MADE HOSPITAL PERSONNEL ILL. NO PTS WERE BEING IMAGED AT THE TIME OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271098 INNOVA 4100 INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB GE MEDICAL SYSTEMS SCS

    Patients

    Seq Age Sex Outcome Treatment
    1