BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AISYS

    MDR report key: 2463508 · Received February 15, 2012

    Report

    Report Number
    2112667-2012-00005
    Event Type
    Injury
    Date Received
    February 15, 2012
    Date of Event
    January 9, 2012
    Report Date
    January 31, 2012
    Manufacturer
    DATEX-OHMEDA INC.
    Product Code
    BSZ
    PMA / PMN Number
    K042154
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    UNDER EUROPEAN LAW AND THE (B)(4) DATA PROTECTION ACT 1998, PATIENT INFORMATION IS CONSIDERED CONFIDENTIAL AND WILL NOT BE RELEASED BY THE HOSPITAL.

    Description of Event or Problem · 1

    ACCORDING TO A (B)(4) REPORT, "DURING A PROCEDURE WHEN THE ANAESTHETIC MACHINE WAS IN USE, THE ODP ON DUTY NOTICED THAT THE CO2 ABSORBER WAS EXHAUSTED. THE ODP REMOVED THE CO2 ABSORBER FROM THE ANAESTHETIC MACHINE, BUT UNDER THE BELIEF THAT THIS WOULD CAUSE A LEAK IN THE PATIENT CIRCUIT, CHANGED THE PATIENT CIRCUIT TO OPERATE FROM THE COMMON GAS OUTLET. THE CIRCUIT CONTAINED A BAG BUT NO EXPIRATION VALVE. GAS WAS INTRODUCED INTO THE CIRCUIT 'POSSIBLY' USING THE EMERGENCY OXYGEN VALVE. AS A RESULT, THE PATIENT'S LUNGS WERE OVERPRESSURISED AND COLLAPSED. THE PATIENT SUFFERED BILATERAL PNEUMOTHORAX. PATIENT FULLY RECOVERED." GE HEALTHCARE'S INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AISYS ANESTHESIA GAS MACHINE BSZ DATEX-OHMEDA INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention