BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AISYS

    MDR report key: 5374391 · Received January 18, 2016

    Report

    Report Number
    2112667-2016-00092
    Event Type
    Malfunction
    Date Received
    January 18, 2016
    Date of Event
    January 9, 2016
    Report Date
    March 23, 2016
    Manufacturer
    DATEX-OHMEDA, INC.
    Product Code
    BSZ
    PMA / PMN Number
    K042154
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT NAME HAS BEEN CORRECTED TO AISYS. (B)(4). PMA/510(K): THIS FIELD HAS BEEN CORRECTED TO K042154. THE DATE OF DEVICE MANUFACTURE HAS BEEN CORRECTED TO 5 AUGUST 2014.

    Additional Manufacturer Narrative · 1

    A GE HEALTHCARE SERVICE REPRESENTATIVE PERFORMED A CHECKOUT OF THE EQUIPMENT. GE HEALTHCARE RECOMMENDED TO THE HOSPITAL TO REPLACE THE CONTROL BOARD. INITIAL REPORTER: THE INITIAL REPORTER IS LOCATED OUTSIDE THE U.S., AND THEREFORE THIS INFORMATION IS NOT PROVIDED DUE TO COUNTRY PRIVACY LAWS.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THE UNIT HAD A BLANK SCREEN AND MECHANICAL VENTILATION WAS NOT FUNCTIONAL. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    32985 AISYS ANESTHESIA GAS MACHINE BSZ DATEX-OHMEDA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1