BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPERDIMENSION INREACH SYSTEM

    MDR report key: 3862929 · Received February 20, 2014

    Report

    Report Number
    3004962788-2014-00009
    Event Type
    Malfunction
    Date Received
    February 20, 2014
    Date of Event
    January 23, 2014
    Report Date
    January 20, 2014
    Manufacturer
    SUPERDIMENSION INC.
    Product Code
    JAK
    PMA / PMN Number
    K092365
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEVICE WAS RECEIVED FOR EVAL. THE SITE SUCCESSFULLY COMPLETED THE CASE. THERE WAS NO HARM OR INJURY REPORTED TO THE PT REPORTED. IN ABUNDANCE OF CAUTION, THIS EVENT IS BEING REPORTED DUE TO THE PTS ADD'L RISK ASSOCIATED WITH MULTIPLE EXPOSURES OF GENERAL ANESTHESIA.

    Description of Event or Problem · 1

    SITE REPORTED TROUBLE LOADING A PLANNING FILE FOR A SUPERDIMENSION CASE. THE PT WAS UNDER GENERAL ANESTHESIA FOR APPROX TWO HOURS, WHEN THE PHYSICIAN WOKE THE PT UP TO BE RE-SCANNED. THE SITE WAS ABLE TO COMPLETE THE SUPERDIMENSION PORTION OF THE CASE WITH A NEW SCAN. THERE WAS NO REPORT OF PT INJURY, DEATH OR OTHER SERIOUS ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106726 SUPERDIMENSION INREACH SYSTEM ELECTROMAGNETIC NAVIGATION BRONCHOSCOPY JAK SUPERDIMENSION INC. AAS00161-20

    Patients

    Seq Age Sex Outcome Treatment
    1