BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPERDIMENSION INREACH SYSTEM

    MDR report key: 2891162 · Received December 21, 2012

    Report

    Report Number
    3004962788-2012-00056
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Date of Event
    December 6, 2012
    Report Date
    December 21, 2012
    Manufacturer
    SUPERDIMENSION INC.
    Product Code
    JAK
    PMA / PMN Number
    K092365
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVALUATION OF THE LOCATION SUB-SYSTEM FOUND A FUSE HAD AN OPEN CIRCUIT. THE LOCATION SUB-SYSTEM WAS REPLACED AND THE SYSTEM PASSED ALL TESTS. SUPERDIMENSIONS IS FILING THIS MDR OUT OF AN ABUNDANCE OF CAUTION DUE TO THE RISKS ASSOCIATED WITH MULTIPLE EXPOSURES TO ANESTHESIA.

    Description of Event or Problem · 1

    SITE REPORTED TROUBLE WITH THE LOCATION SUB-SYSTEM, A COMPONENT, OF THE SUPERDIMENSION 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
    1 SUPERDIMENSION INREACH SYSTEM ELECTROMAGNETIC NAVIGATION BRONCHOSCOPY JAK SUPERDIMENSION INC. AAS00161-12

    Patients

    Seq Age Sex Outcome Treatment
    1