BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AESTIVA 3000

    MDR report key: 4954209 · Received July 30, 2015

    Report

    Report Number
    2112667-2015-00054
    Event Type
    Injury
    Date Received
    July 30, 2015
    Date of Event
    March 5, 2013
    Report Date
    March 18, 2013
    Manufacturer
    DATEX-OHMEDA, INC
    Product Code
    BSZ
    PMA / PMN Number
    K973896
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    GE HEALTHCARE (GEHC) WAS NOTIFIED OF THE INITIAL COMPLAINT ON (B)(6) 2013. AT THE TIME, THE CUSTOMER REPORTED THE SYSTEM WOULD NOT PROPERLY BOOT UP. THERE WAS NO REPORTED PATIENT INJURY. A GEHC SERVICE REPRESENTATIVE PERFORMED A CHECKOUT OF THE EQUIPMENT, AND REPLACED THE CPU. THE PART WAS SUBSEQUENTLY DISCARDED. IN JULY 2015, GEHC WAS NOTIFIED VIA A LEGAL COMPLAINT THAT THE PATIENT WAS INADEQUATELY OXYGENATED DURING A SURGICAL PROCEDURE, CAUSING PERMANENT BRAIN DAMAGE. DUE TO OPEN LITIGATION, CUSTOMER RESPONSE TO ALL INVESTIGATION QUESTIONS WERE ANSWERED, "UNDETERMINED PENDING OUTCOME OF ONGOING LITIGATION".

    Description of Event or Problem · 1

    GE HEALTHCARE HAS BEEN NOTIFIED OF A LEGAL CLAIM IN WHICH IT IS ALLEGED THAT THE MECHANICAL VENTILATOR FAILED AND THE PATIENT INCURRED BRAIN DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    497090 AESTIVA 3000 ANESTHESIA GAS MACHINE BSZ DATEX-OHMEDA, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Disability