BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPERDIMENSION INREACH SYSTEM

    MDR report key: 2980130 · Received February 21, 2013

    Report

    Report Number
    3004962788-2013-00005
    Event Type
    Malfunction
    Date Received
    February 21, 2013
    Date of Event
    January 22, 2013
    Report Date
    February 21, 2013
    Manufacturer
    SUPERDIMENSION INC.
    Product Code
    JAK
    PMA / PMN Number
    K092365
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SITE DID NOT RETURN ANY COMPONENT OF THE SUPERDIMENSION SYSTEM FOR EVAL. BASED ON THE EVENT DESCRIPTION AND PREVIOUS INVESTIGATIONS, A SOFTWARE ANOMALY BUG WAS IDENTIFIED AND RESOLVED. SUPERDIMENSION IS FILING THIS MDR IN AN ABUNDANCE OF CAUTION DUE TO THE RISK ASSOCIATED WITH MULTIPLE EXPOSURES TO ANESTHESIA.

    Description of Event or Problem · 1

    SITE REPORTED TROUBLE LOADING THE PLANNING FILE ON THE SUPERDIMENSION INREACH SYSTEM. THE SUPERDIMENSION PORTION OF THE CASE WAS CANCELLED AND 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
    77410 SUPERDIMENSION INREACH SYSTEM ELECTROMAGNETIC NAVIGATIONN BRONCHOSCOPY JAK SUPERDIMENSION INC. AAS00161-12

    Patients

    Seq Age Sex Outcome Treatment
    1