BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANCE

    MDR report key: 3131090 · Received May 23, 2013

    Report

    Report Number
    2112667-2013-00016
    Event Type
    Injury
    Date Received
    May 23, 2013
    Date of Event
    April 30, 2013
    Report Date
    April 30, 2013
    Manufacturer
    DATEX-OHMEDA
    Product Code
    BSZ
    PMA / PMN Number
    K032803
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    GE HEALTHCARE'S INVESTIGATION IS ONGOING. A F/U REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT A VENTILATOR DEPENDENT TERMINAL PT WAS HAVING A TRACH PLACED. DURING THE SURGICAL PROCEDURE, THE ADJUSTABLE PRESSURE LIMITING (APL) VALVE WAS REPORTEDLY NOTED TO STICK CLOSED. THE PT EXPERIENCED A COLLAPSED LUNG, AND A CHEST TUBE WAS PLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230377 ADVANCE ANESTHESIA GAS MACHINE BSZ DATEX-OHMEDA

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention