BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AISYS

    MDR report key: 3093604 · Received May 1, 2013

    Report

    Report Number
    2112667-2013-00009
    Event Type
    Injury
    Date Received
    May 1, 2013
    Report Date
    April 11, 2013
    Manufacturer
    DATEX-OHMEDA
    Product Code
    BSZ
    PMA / PMN Number
    K042154
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT ID, WEIGHT, AND DATE OF EVENT WOULD NOT BE RELEASED BY THE (B)(6) OF QUALITY HEALTH CARE. ACCORDING TO THE INITIAL REPORTING SITE, THE EVENT OCCURRED AT (B)(6). NO FURTHER CONTACT INFORMATION FOR (B)(6) WAS PROVIDED. A CONTACT NAME FROM THE INITIAL REPORTING SITE WAS NOT PROVIDED. GE HEALTHCARE'S INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THE FOLLOWING EVENT TO THE (B)(6) OF QUALITY HEALTH CARE. THE PATIENT REPORTEDLY MOVED, DISCONNECTING THE BREATHING CIRCUIT FROM THE INSPIRATORY PORT OF THE ANESTHESIA MACHINE. THE CLINICIAN INADVERTENTLY RECONNECTED THE BREATHING CIRCUIT TO THE ACGO PORT. APPROXIMATELY 4 MINUTES LATER, THE PATIENT WAS NOTED TO BE HYPOXIC. ANOTHER PHYSICIAN NOTED THE MISCONNECTION AND SUBSEQUENTLY RECONNECTED THE BREATHING CIRCUIT CORRECTLY. THE CASE WAS CONTINUED. THE PATIENT REPORTEDLY RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    190414 AISYS ANESTHESIA GAS MACHINE BSZ DATEX-OHMEDA

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Required Intervention