BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GE HEALTHCARE 55ADV

    MDR report key: 621112 · Received July 5, 2005

    Report

    Report Number
    621112
    Event Type
    Injury
    Date Received
    July 5, 2005
    Date of Event
    June 23, 2005
    Report Date
    July 2, 2005
    Manufacturer
    GE HEALTHCARE
    Product Code
    BSZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT THAT HAD BEEN IN TERMINAL SHOCK AFTER AN EARLIER CARDIAC ARREST WAS BROUGHT TO THE OR FOR EX-LAP. PULA ART CATH CVC PHARED. MANVAL VENTILATION ON ANESTHESIA MACHINE DURING CXT FOR LINE PLACEMENT. ON SWITCHING BACK TO VENT MODE VENTILATOR FAILED TO CYCLE, AND DID NOT GIVE AN AUDIBLE ALARM. (AS REPORTED BY COMPANY SERVICE REP. CPV DRIVING VENTILATOR FAILED.) THIS WAS NOTED VERY QUICKLY BY ANESTHESIA TEAM AND MANUAL VENTILATION RESUMED (SECONDS). PT SUFFERED A CARDIAC ARREST SOON THERE AFTER AND WAS RESUCIATED ONLY TO DIE IN ICU HOURS LATER FROM ISCHEMIC BOWEL THAT COULD NOT BE RESECTED. IT IS THE OPINION OF THE ANESTHESIA TEAM THAT THE VENT MALFUNCTION WAS BRIEF ENOUGH THAT IT DID NOT SPECIFICALLY CAUSE THE ARREST-MANY OTHER FACTORS WERE OCCURRING SIMULTANEOUSLY; TERMINAL SHOCK, HYPO-KALEMIA, ACIDOSIS, HYPOCALCEMIA, WEISENING PULM FUNCTION HOWEVER MALFUNCTION SHOULD BE COMMUNICATED TO OTHER MACHINE USERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GE HEALTHCARE 55ADV ANESTHESIA MACHINE BSZ GE HEALTHCARE 55ADV0ZLD-STD *

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other| R