BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    A5 ANESTHESIA DELIVERY SYSTEM

    MDR report key: 4479803 · Received January 12, 2015

    Report

    Report Number
    2221819-2014-01123
    Event Type
    Malfunction
    Date Received
    January 12, 2015
    Date of Event
    November 21, 2014
    Report Date
    November 21, 2014
    Manufacturer
    MINDRAY BIO-MEDICAL ELECTRONICS CO. LTD.
    Product Code
    CBQ
    PMA / PMN Number
    K123211
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    COMPANY REPRESENTATIVE EVALUATED THE SYSTEM. CORRECTIONS INCLUDED REPLACEMENT OF THE SYSTEM'S CPU BOARD, RELOADING SYSTEM'S SOFTWARE, AND CALIBRATING. SYSTEM WAS TESTED TO FACTORY'S SPECIFICATIONS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED AN ISSUE WITH THE A5 ANESTHESIA DELIVERY SYSTEM DISPLAY, WHICH MAY HAVE AFFECTED ANESTHESIA MONITORING. NO PATIENT MONITORING WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27711 A5 ANESTHESIA DELIVERY SYSTEM ANESTHESIA DELIVERY SYSTEM CBQ MINDRAY BIO-MEDICAL ELECTRONICS CO. LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1