BEUDAMED
    FDA Adverse Event Other Summary report: N

    NARKOMED

    MDR report key: 676667 · Received February 14, 2006

    Report

    Report Number
    2517967-2006-00007
    Event Type
    Other
    Date Received
    February 14, 2006
    Date of Event
    January 4, 2006
    Report Date
    January 4, 2006
    Manufacturer
    DRAEGER MEDICAL, INC.
    Product Code
    BSZ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: WHILE THE DEVICE WAS IN USE ON A PATIENT, THE DEVICE BRIEFLY FLASHED A 522 ERROR THEN IT CAME UP SHOWING A DC POWER FAILURE. IT ALSO THEN INDICATED A VENT. COMM LOSS MESSAGE. THE INITIAL REPORTER STATED THAT WHEN THE CONDITION OCCURRED, THE INITIAL REPORTER DEPRESSED THE VENTILATOR OVERRIDE BUTTON AND THE LIGHT CAME ON. THE USER ATTEMPTED TO VENTILATE THE PATIENT ON THE MACHINE: HOWEVER, WAS UNABLE TO BILD PRESSURE. THE USER MANUALLY VENTILATED THE PATIENT WITH AN ALTERNATE DEVICE TO COMPLETE THE CASE. AFTER THE CASE, IT WAS DETERMINED THAT THE AC LINE CORD HAD BECOME UNPLUGGED. ANOTHER DOCTOR CHECKED THE MACHINE AND FOUND IT TO FUNCTION NORMALLY. NO PATIENT INJURY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other