BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPERDIMENSION INREACH SYSTEM

    MDR report key: 6056926 · Received October 26, 2016

    Report

    Report Number
    3004962788-2016-00286
    Event Type
    Malfunction
    Date Received
    October 26, 2016
    Date of Event
    September 20, 2016
    Report Date
    September 20, 2016
    Manufacturer
    SUPERDIMENSION INC.
    Product Code
    JAK
    UDI-DI
    10884521199989
    PMA / PMN Number
    K092365
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PST CABLE WAS NOT RETURNED FOR EVALUATION. 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 DUE TO THE ADDITIONAL RISK ASSOCIATED WITH MULTIPLE EXPOSURES TO GENERAL ANESTHESIA.

    Description of Event or Problem · 1

    SITE REPORTED ONE OF THREE PATIENT SENSOR TRIPLET (PST) SENSORS WAS NOT DETECTED DURING AN ENB PROCEDURE. THE SITE DID NOT HAVE ANOTHER PST CABLE FOR TROUBLESHOOTING AND THEREFORE THE PHYSICIAN CANCELLED THE CASE. THE PATIENT WAS UNDER GENERAL ANESTHESIA. THERE WAS NO REPORT OF PATIENT INJURY, DEATH OR OTHER SERIOUS ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    707502 SUPERDIMENSION INREACH SYSTEM ELECTROMAGNETIC NAVIGATION BRONCHOSCOPY JAK SUPERDIMENSION INC. AAS00161-20 10884521199989

    Patients

    Seq Age Sex Outcome Treatment
    1