BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INNOVA 2100-IQ

    MDR report key: 2615887 · Received June 12, 2012

    Report

    Report Number
    9611343-2012-00025
    Event Type
    Malfunction
    Date Received
    June 12, 2012
    Date of Event
    May 16, 2012
    Report Date
    May 16, 2012
    Manufacturer
    GE MEDICAL SYSTEMS SCS
    Product Code
    MQB
    PMA / PMN Number
    K033244
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CIRCLIP AND A WASHER OF THE MONITOR SUSPENSION PIVOT CAME OFF AND FELL TO THE GROUND. WITHOUT THE WASHER IN PLACE, THE SUSPENSION SYSTEM FOR THE MONITOR BECOMES COMPROMISED AND MAY NOT ADEQUATELY SUPPORT THE MONITOR. GE HEALTHCARE'S INVESTIGATION IS ONGOING. A F/U REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INNOVA 2100-IQ FLUOROSCOPIC X-RAY SYSTEM MQB GE MEDICAL SYSTEMS SCS

    Patients

    Seq Age Sex Outcome Treatment
    1