BEUDAMED
    FDA Adverse Event Death Summary report: N

    NARKOMED

    MDR report key: 2190488 · Received July 28, 2011

    Report

    Report Number
    2510954-2011-00001
    Event Type
    Death
    Date Received
    July 28, 2011
    Date of Event
    June 28, 2011
    Report Date
    June 29, 2011
    Manufacturer
    DRAEGER MEDICAL SYSTEMS, INC. (PNC)
    Product Code
    BSZ
    PMA / PMN Number
    K033498
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FACILITY WAS CONTACTED ON (B)(6) 2011 AND THE BIOMED TECHNICIAN SAID THAT HE PERFORMED A COMPLETE DAILY/PRE USE CHECKOUT OF THE DEVICE AFTER THE REPORTED INCIDENT AND THE DEVICE PASSED ALL TESTS. THE DEVICE WAS PLACED BACK INTO USE AND WAS ACTUALLY IN USE AT THE TIME OF THE PHONE CALL AND THERE WERE NO REPORTED PROBLEMS. THE DEVICE LOGS WERE DOWNLOADED AND WERE SENT TO THE MFR FOR ANALYSIS. THE ANALYSIS OF THE LOGS DID NOT INDICATE ANY DEVICE MALFUNCTIONING DURING THE PERIOD OF THE REPORTED INCIDENT. THE DEVICE LOGS DID INDICATE THAT THERE WERE VARIOUS PT PARAMETER ALARMS ANNUNCIATED DURING THE CASE. CONCLUSION: BASED ON THE INFO REPORTED BY THE BIOMED TECHNICIAN AND THE DEVICE LOG ANALYSIS, THERE IS NO INDICATION OF A DEVICE FAILURE/MALFUNCTION. THE DEVICE LOG ANALYSIS INDICATED THAT THE DEVICE OPERATED AS INTENDED DURING THE PERIOD OF THE REPORTED INCIDENT. ALARMS WERE APPROPRIATELY GENERATED WHEN MEASURED PT PARAMETERS EXCEEDED THE ALARM LIMITS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE THAT INVOLVED THE USE OF ROBOTICS, THE PT WENT INTO CARDIAC ARREST AND COULD NOT BE REVIVED. IN DISCUSSIONS WITH FACILITY PERSONNEL, IT WAS BELIEVED THAT DURING THE PROCEDURE, THE PT BEGAN TO BLEED INTERNALLY, POSSIBLY AS A RESULT OF THE ROBOTIC INSTRUMENT NICKING AN ARTERY. THE CLINICIAN ATTEMPTED TO PUMP MORE BLOOD INTO THE PT BUT THE PT COULD NOT BE REVIVED. THERE WAS NO ALLEGED DEVICE MALFUNCTION NOR WAS IT ALLEGED THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NARKOMED ANESTHESIA MACHINE BSZ DRAEGER MEDICAL SYSTEMS, INC. (PNC) 6400 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death