BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPERDIMENSION INREACH BRONCHUS SYSTEM

    MDR report key: 4073295 · Received June 20, 2014

    Report

    Report Number
    3004962788-2014-00033
    Event Type
    Malfunction
    Date Received
    June 20, 2014
    Date of Event
    May 27, 2014
    Report Date
    June 20, 2014
    Manufacturer
    SUPERDIMENSION INC.
    Product Code
    JAK
    PMA / PMN Number
    K092365
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PHONE TROUBLESHOOTING FOUND THAT THE VIDEO CONNECTION WAS LOOSE. BIOMED WAS ABLE TO CORRECT THE LOOSE CONNECTION. THERE WERE NO ANOMALIES IDENTIFIED DURING THE INTERNAL REVIEW OF THE DHR OF THE SYSTEM CONSOLE. OUT OF AN ABUNDANCE OF CAUTION, SUPERDIMENSION IS FILING THIS MDR BECAUSE OF THE ADD'L RISK ASSOCIATED WITH MULTIPLE EXPOSURES TO GENERAL ANESTHESIA.

    Description of Event or Problem · 1

    SITE REPORTED THE SUPERDIMENSION ILOGIC SYSTEM HAD NO VIDEO DISPLAY AND THE PHYSICIAN CANCELED THE SUPERDIMENSION PORTION OF THE CASE. THE PT WAS UNDER GENERAL ANESTHESIA. THERE WAS NO REPORT OF PT INJURY, DEATH OR OTHER SERIOUS ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    363323 SUPERDIMENSION INREACH BRONCHUS SYSTEM ELECTROMAGNETIC NAVIGATION BRONCHOS JAK SUPERDIMENSION INC. AAS00161-12

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR