BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AISYS

    MDR report key: 4902041 · Received July 9, 2015

    Report

    Report Number
    2112667-2015-00032
    Event Type
    Injury
    Date Received
    July 9, 2015
    Date of Event
    April 3, 2013
    Report Date
    April 3, 2013
    Manufacturer
    DATEX-OHMEDA, INC
    Product Code
    BSZ
    PMA / PMN Number
    K042154
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    AS THE EVENT OCCURRED ON (B)(6) 2013, PATIENT INFORMATION IS NO LONGER AVAILABLE. GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS STILL ONGOING. A FOLLOW-UP REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    A GE HEALTHCARE SERVICE REPRESENTATIVE PERFORMED A CHECKOUT OF THE EQUIPMENT, AND THE REPORTED COMPLAINT WAS CONFIRMED. THE LOGS WERE REVIEWED AND MULTIPLE ENTRIES OF A KEYPRESS BEING STUCK ON WAS NOTED. THE KEYPAD WAS REPLACED AND THE UNIT WAS RETURNED TO SERVICE. THE KEYPAD WAS NOT AVAILABLE FOR INVESTIGATION. THE EXACT ROOT CAUSE OF THE REPORTED COMPLAINT CANNOT BE DETERMINED WITHOUT A SAMPLE.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT, DURING A CASE, THE VENTILATOR SCREEN FROZE. THE CLINICIAN SWITCHED TO AUXILIARY OXYGEN AND MANUALLY VENTILATED THE PATIENT WHILE THEY SWAPPED THE UNIT. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447218 AISYS ANESTHESIA GAS MACHINE BSZ DATEX-OHMEDA, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention