BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AISYS CS2

    MDR report key: 6215431 · Received December 30, 2016

    Report

    Report Number
    2112667-2016-02564
    Event Type
    Malfunction
    Date Received
    December 30, 2016
    Date of Event
    December 2, 2016
    Report Date
    December 30, 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

    THE INITIAL REPORTER IS LOCATED OUTSIDE THE U.S., AND THEREFORE THIS INFORMATION IS NOT PROVIDED DUE TO COUNTRY PRIVACY LAWS. GE HEALTHCARE ISSUED A QUOTE RECOMMENDING REPLACEMENT OF THE ANESTHESIA CONTROL BOARD AND THE CARRIER BOARD. TO DATE, THE QUOTE HAS NOT BEEN ACCEPTED.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT, DURING A CASE, THE UNIT SHUT DOWN. THE CLINICIAN REPORTEDLY CYCLED POWER AND COMPLETED THE CASE WITH NO FURTHER REPORTED COMPLAINT. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    865617 AISYS CS2 ANESTHESIA GAS MACHINE BSZ DATEX-OHMEDA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1