BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AESPIRE VIEW

    MDR report key: 8789812 · Received July 15, 2019

    Report

    Report Number
    2112667-2019-00290
    Event Type
    Malfunction
    Date Received
    July 15, 2019
    Report Date
    July 15, 2019
    Manufacturer
    DATEX-OHMEDA, INC.
    Product Code
    BSZ
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOR THE REPORTED EVENT, A GE HEALTHCARE SERVICE REPRESENTATIVE PERFORMED A CHECKOUT OF THE SYSTEM AND DID NOT CONFIRM THE REPORTED EVENT.

    Description of Event or Problem · 1

    THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT. A REVIEW OF THE EVENT INDICATED THAT MODEL 1009-9212-000 ANESTHESIA GAS MACHINE EXPERIENCED SUDDEN RESTART ON ITS OWN RESULTING IN THE LOSS OF MECHANICAL VENTILATION. THE REPORT WAS RECEIVED FROM A SINGLE SOURCE. THE REPORTED EVENT DID NOT INVOLVE A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581589 AESPIRE VIEW ANESTHESIA GAS MACHINE BSZ DATEX-OHMEDA, INC. 1009-9212-000

    Patients

    Seq Age Sex Outcome Treatment
    1