BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APOLLO

    MDR report key: 3170650 · Received June 10, 2013

    Report

    Report Number
    2517967-2013-00003
    Event Type
    Injury
    Date Received
    June 10, 2013
    Date of Event
    June 3, 2013
    Report Date
    June 4, 2013
    Manufacturer
    DRAEGER MEDICAL GMBH
    Product Code
    BSZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    AZ, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CASE, THE APOLLO BEGAN TO ALARM FOR 'FLOW SENSOR INOP' AND FLOW VALUES STOPPED BEING DISPLAYED. IT WAS REPORTED THAT THE DOCTOR INCREASED THE FLOWS TO TRY TO RESTORE THE DISPLAY OF VALUES. THE PT REPORTEDLY DEVELOPED A PNEUMOTHORAX. THE CASE WAS COMPLETED. AN EVAL OF THE DEVICE INDICATED THAT THE EXPIRATORY FLOW SENSOR WAS FAULTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261669 APOLLO ANESTHESIA MACHINE BSZ DRAEGER MEDICAL GMBH NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention