BEUDAMED
    FDA Adverse Event Summary report: N

    SERVO-I

    MDR report key: 3121754 · Received May 8, 2013

    Report

    Report Number
    3008355164-2013-00111
    Date Received
    May 8, 2013
    Date of Event
    December 28, 2012
    Report Date
    April 10, 2013
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT THE EDI CATHETER WAS ERRONEOUSLY ENTERED INTO THE RIGHT MAIN BRONCHUS INSTEAD OF THE STOMACH. THE MISPLACEMENT WAS NOT INITIALLY NOTICED UNTIL MEDICATION WAS ADMINISTERED INTO IT. A CHEST X-RAY CONFIRMED THE EDI CATHETER IN THE RIGHT MAIN BRONCHUS. THE PATIENT DID NOT SUFFER ANY PULMONARY CONSEQUENCES. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202266 SERVO-I CBK MAQUET CRITICAL CARE AB NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR Other