BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OVATION 3

    MDR report key: 1140566 · Received August 28, 2008

    Report

    Report Number
    9612283-2008-00002
    Event Type
    Malfunction
    Date Received
    August 28, 2008
    Date of Event
    July 1, 2008
    Report Date
    July 1, 2008
    Manufacturer
    GE YOKOGAWA MEDICAL SYSTEMS
    Product Code
    LNH
    PMA / PMN Number
    K002611
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE GE FIELD ENGINEER (FE) INSPECTED THE DEVICE AND OBSERVED THE TABLE DID NOT ELEVATE WHEN THE UP-PEDAL WAS PRESSED. THE FE WAS ABLE TO ELEVATE THE TABLE WHEN THE TABLE CONTROL BOARD WAS REPLACED. TO DUPLICATE THE REPORTED ISSUE, THE FE EXTENDED THE CRADLE INTO THE BORE AFTER ELEVATING THE TABLE AND PRESSED ON THE DOWN-PEDAL. THE TABLE WAS FOUND TO BE PERFORMING PER SPECIFICATIONS BECAUSE IT DID NOT LOWER WHILE THE CRADLE WAS EXTENDED. THIS WAS ATTEMPTED SEVERAL TIMES BY THE FE WITH NO SUCCESS.

    Description of Event or Problem · 1

    THE SITE REPORTED THAT A PATIENT WITH A LEFT SHOULDER PAIN WAS SCANNED FOR AN MR SHOULDER EXAM. DURING THE EXAM, THE TABLE SUPPORT SPONTANEOUSLY LOWERED SLOWLY, CAUSING THE CRADLE TO TILT. THE CRADLE CONTAINED THE PATIENT AND WAS INSIDE THE BORE AT THIS TIME. THE PATIENT'S HEAD CONTACTED THE TOP OF THE MAGNET BORE. THE PATIENT WAS ABLE TO GET HIMSELF OFF THE TABLE AND OUT OF THE MR SCANNER. DURING THIS TIME, THE TECHNOLOGIST OBSERVED THE EVENT AND PRESSED THE EMERGENCY STOP BUTTON AND PROCEEDED TO THE MAGNET ROOM. A RADIOLOGIST EXAMINED THE PATIENT AND OBSERVED A RED MARK ON THE PATIENT'S FOREHEAD. IN ADDITION, THE PATIENT REPORTED FEELING DIZZY. THE RADIOLOGIST HAD THE PATIENT STAY FOR 20 MINUTES AND THEN BE RE-EXAMINED. AT THIS TIME, THE MARK DISAPPEARED. THE PATIENT LEFT THE FACILITY. THE PATIENT THEN SOUGHT AN ER PHYSICIAN. THE PHYSICIAN ORDERED A CT SCAN FOR THE PATIENT'S HEAD AS WELL AS X-RAY FOR THE PATIENT'S SHOULDER SINCE THE MRI EXAM WAS NOT COMPLETED. THE PATIENT REFUSED THE CT SCAN. THE SITE HAD NOT HEARD OF ANY OTHER TREATMENT OR DIAGNOSIS OF THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OVATION 3 LNH GE YOKOGAWA MEDICAL SYSTEMS 2262700-2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR