BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NARKOMED

    MDR report key: 1617338 · Received February 22, 2010

    Report

    Report Number
    2510954-2010-00002
    Event Type
    Injury
    Date Received
    February 22, 2010
    Date of Event
    January 24, 2010
    Report Date
    January 25, 2010
    Manufacturer
    DRAEGER MEDICAL SYSTEMS, INC. (PNC)
    Product Code
    BSZ
    PMA / PMN Number
    K971425
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY HAS AT LEAST TWO TYPES OF DRAEGER ANESTHESIA MACHINES; THE NARKOMED MRI AND THE NARKOMED MOBILE. THE NARKOMED MRI IS CLEARED FOR USE IN AN MR ENVIRONMENT WITH MAGNET STRENGTHS UP TO 3 TESLA. THE NARKOMED MOBILE IS NOT CLEARED FOR USE IN AN MR ENVIRONMENT. IN CONVERSATIONS WITH THE FACILITY, IT WAS DETERMINED THAT THE ANESTHESIOLOGIST CALLED FOR A TECH TO BRING A NARKOMED MRI ANESTHESIA MACHINE INTO THE MR SUITE. THE TECH MISTAKENLY BROUGHT IN A NARKOMED MOBILE ANESTHESIA MACHINE. DUE TO THE FERROUS MATERIAL CONTENT OF THE NARKOMED MOBILE AND THE TWO CYLINDERS MOUNTED ON THE MACHINE, IT WAS ATTRACTED TO, AND MOVED TOWARDS THE MR MAGNET. THE ANESTHESIOLOGIST TRIED TO STOP THE MOVEMENT AND BECAME PINNED BETWEEN THE DEVICE AND THE MR MAGNET. THE NARKOMED MOBILE WAS EVALUATED BY A DRAEGER SERVICE TECH. HE DEVICE SUSTAINED SOME STRUCTURAL DAMAGE, BUT WAS ABLE TO BE REPAIRED AND PLACED BACK INTO SERVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A TECH BROUGHT A NARKOMED MOBILE ANESTHESIA MACHINE INTO AN MRI ROOM BY MISTAKE. THE NARKOMED MOBILE WAS PULLED INTO CONTACT WITH THE MRI MACHINE PINNING THE ANESTHESIOLOGIST'S ARM BETWEEN THE MRI MACHINE AND THE NARKOMED MOBILE. THE ANESTHESIOLOGIST REPORTEDLY SUSTAINED NERVE DAMAGE TO THE AFFECTED ARM THAT REQUIRED SURGERY TO REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NARKOMED ANESTHESIA MACHINE BSZ DRAEGER MEDICAL SYSTEMS, INC. (PNC) MOBILE NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization