BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INNOVA 2000

    MDR report key: 4180514 · Received October 15, 2014

    Report

    Report Number
    9611343-2014-00073
    Event Type
    Malfunction
    Date Received
    October 15, 2014
    Date of Event
    September 16, 2014
    Report Date
    September 16, 2014
    Manufacturer
    GE MEDICAL SYSTEMS SCS
    Product Code
    OWB
    PMA / PMN Number
    K0222322
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    GE HEALTHCARE'S INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    GE HEALTHCARE INVESTIGATION HAS BEEN COMPLETED. THE ROOT-CAUSE IDENTIFIED FOR THIS ISSUE IS A "SERVICE ERROR" DUE TO THE SCREWS BEING NOT ORIGINALLY FIXED EITHER AT THE TIME OF SYSTEM INSTALLATION OR DURING MONITOR REPLACEMENT AS PER THE SERVICE MANUAL'S INSTRUCTIONS PROVIDED WITH THE SYSTEM. INVESTIGATION SHOWS THAT THE CRT MONITORS CANNOT FALL IN NORMAL CLINICAL WORKFLOW. IT HAS BEEN ALSO DETERMINED THAT THIS IS AN ISOLATED ISSUE TO 2 SITES (INCLUDING THE SITE IN THIS REPORT AND MDR# 9611343-2014-00072 AND 9611343-2014-00074, AND THE SITE IN MDR# 9611343-2014-00071), WHICH WERE CORRECTED BY A GE HEALTHCARE FIELD SERVICE ENGINEER WHEN SERVICING THE SYSTEMS BY FIXING CRT MONITORS WITH APPROPRIATE SCREWS IN THE MISSING LOCATIONS. NO FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SOME SCREWS HOLDING THE CRT MONITORS ON THE OVERHEAD BOOM OF THE BRIDGE ARE MISSING, NO CRT MONITOR FALL AND NO INJURY HAS BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    654500 INNOVA 2000 INTERVENTIONAL FLUOROSCOPIC X-RAY OWB GE MEDICAL SYSTEMS SCS

    Patients

    Seq Age Sex Outcome Treatment
    1