BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    E-GAS COMPACT AIRWAY MODULE

    MDR report key: 1719478 · Received June 7, 2010

    Report

    Report Number
    MW5016270
    Event Type
    Malfunction
    Date Received
    June 7, 2010
    Date of Event
    April 29, 2010
    Report Date
    June 7, 2010
    Manufacturer
    GE
    Product Code
    BSZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    DURING USE OF GE E-CAIO-00 ANESTHESIA GAS MODULE, UNIT STOPPED SHOWING ANESTHETIC AGENT READINGS, FIELD WENT TO DASHES. WHEN TESTED IN SHOP, UNIT CAME UP WITH A "FAILURE TO ID AGENT" ALERT IN DATA FIELD. THIS HAS HAPPENED TO TWO DIFFERENT UNITS AND THEY HAVE BEEN SENT IN TO GE FOR DEPOT REPAIR. WE HAVE ALSO HAD NO AGENT READING AT THE START OF A CASE, SEVERAL TIMES, AND UNITS HAVE BEEN SWAPPED WITH AN OPERATIONAL ONE, TO BE CALIBRATED AND TESTED LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 E-GAS COMPACT AIRWAY MODULE ANESTHESIA GAS ANALYZER BSZ GE E-CAIO-00
    2 E-GAS COMPACT AIRWAY MODULE ANESTHESIA GAS ANALYZER BSZ GE E-CAIO-00

    Patients

    Seq Age Sex Outcome Treatment
    1