BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KION

    MDR report key: 1020223 · Received March 20, 2008

    Report

    Report Number
    1225700-2008-00042
    Event Type
    Injury
    Date Received
    March 20, 2008
    Date of Event
    February 29, 2008
    Report Date
    March 3, 2008
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    BSZ
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    FR
    Reporter Occupation
    NO INFORMATION

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT DURING THE START OF THE ANESTHESIA PROCESS THE STAFF OBSERVED THAT THE PT WAS STILL RESTLESS AND A NEW DOSE OF ANESTHETICS WAS GIVEN. SHORTLY AFTERWARDS THE PT COULD NOT BREATHE ANYMORE AND THE SATURATION FELL AND THE PT TURNED BLUE. THE STAFF THEN CONNECTED THE PT TO THE ANESTHESIA MACHINE IN MANUAL VENTILATION MODE. THE MANUAL BREATHING BAG DID NOT INFLATE AND THERE WAS NO INSPIRATION. SWITCH TO A CONTROL MODE (VOLUME CONTROL AND LATER PRESSURE CONTROL) CIRCLE SYSTEM, DID NOT RESOLVE THE PROBLEM. THE AUXILIARY FRESH GAS OUTLET WAS OPENED IN ORDER TO VENTILATE THE PT WITH A RESUSCITATOR. AFTER THAT, THE MEDICAL STAFF SWITCHED BACK TO A CONTROL MODE. THE ANESTHESIA MACHINE WORKED NORMALLY AND THE SURGERY ENDED WITHOUT PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KION BSZ BSZ MAQUET CRITICAL CARE AB * *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Life Threatening| R