BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AISYS CS2

    MDR report key: 5822635 · Received July 26, 2016

    Report

    Report Number
    2112667-2016-01415
    Event Type
    Malfunction
    Date Received
    July 26, 2016
    Date of Event
    July 1, 2016
    Report Date
    July 26, 2016
    Manufacturer
    DATEX-OHMEDA, INC.
    Product Code
    BSZ
    PMA / PMN Number
    K132530
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). GE HEALTHCARE SERVICE REPRESENTATIVE PERFORMED A CHECKOUT OF THE EQUIPMENT AND A REVIEW OF THE LOGS. THE GAS INLET VALVE WAS REPLACED.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT, DURING THE BOOT-UP PROCESS, THE UNIT ALARMED THAT MECHANICAL VENTILATION WAS NOT FUNCTIONAL. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    475809 AISYS CS2 ANESTHESIA GAS MACHINE BSZ DATEX-OHMEDA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1