BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPERDIMENSION INREACH SYSTEM

    MDR report key: 3243082 · Received July 18, 2013

    Report

    Report Number
    3004962788-2013-00022
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    June 19, 2013
    Report Date
    July 18, 2013
    Manufacturer
    SUPERDIMENSION INC.
    Product Code
    JAK
    PMA / PMN Number
    K092365
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SUPERDIMENSION HAS NOT YET RECEIVED THE LOCATION SUBSYSTEM FROM THE SITE FOR EVAL. SUPERDIMENSION IS FILING THIS MDR IN AN ABUNDANCE OF CAUTION DUE TO THE RISKS ASSOCIATED WITH MULTIPLE EXPOSURES TO ANESTHESIA.

    Description of Event or Problem · 1

    SITE REPORTED DIFFICULTY WITH THE LOCATION SUBSYSTEM, A COMPONENT OF THE SUPERDIMENSION INREACH SYSTEM, AND CANCELED THE SUPERDIMENSION CASE. THE PT WAS UNDER GENERAL ANESTHESIA AND THERE WAS NO REPORT OF PT INJURY, DEATH OR OTHER SERIOUS ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335550 SUPERDIMENSION INREACH SYSTEM ELECTROMAGNETIC NAVIAGATION BRONCHOSCOPY JAK SUPERDIMENSION INC. AAS00161-12R

    Patients

    Seq Age Sex Outcome Treatment
    1