BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INNOVA 2000

    MDR report key: 1860185 · Received September 21, 2010

    Report

    Report Number
    9611343-2010-00010
    Event Type
    Malfunction
    Date Received
    September 21, 2010
    Date of Event
    August 14, 2010
    Report Date
    September 21, 2010
    Manufacturer
    GE MEDICAL SYSTEMS SCS
    Product Code
    MQB
    PMA / PMN Number
    K022322
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT A DOCTOR WAS OPERATING THE TABLE OF THE INNOVA 2000 WITH THE SMART BOX (TABLESIDE CONTROL), WHEN THE CONTROL CAME OFF OF THE RAIL, FELL TO THE FLOOR AND LANDED ON THE DOCTOR'S TOE. FOLLOWING THE EVENT, THE DOCTOR WAS REPORTEDLY INCAPACITATED FOR APPROXIMATELY FIVE (5) MINUTES. IT WAS CONFIRMED THROUGH SUBSEQUENT FOLLOW UP THAT THE INJURIES SUSTAINED BY THE DOCTOR INCLUDED BRUISING AND PAIN. NO SERIOUS INJURY WAS REPORTED. ACCORDING TO THE CUSTOMER, THE MECHANISM THAT CONNECTED THE SMART BOX TO THE TABLE WAS "WORN AND ROUNDED." THE SMART BOX WAS REPLACED AT THE CUSTOMER SITE. GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS STILL ONGOING. A FOLLOW-UP REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INNOVA 2000 VASCULAR X-RAY SYSTEM MQB GE MEDICAL SYSTEMS SCS OMEGA IV 2320045

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR