BEUDAMED
    FDA Adverse Event Death Summary report: N

    A5 ANESTHESIA SYSTEM

    MDR report key: 3093850 · Received May 1, 2013

    Report

    Report Number
    2221819-2013-00962
    Event Type
    Death
    Date Received
    May 1, 2013
    Date of Event
    April 2, 2013
    Report Date
    April 30, 2013
    Manufacturer
    MINDRAY DS USA, INC.
    Product Code
    BSZ
    PMA / PMN Number
    123211
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    A MINDRAY SERVICE REPRESENTATIVE EVALUATED THE SYSTEM, PERFORMED A FULL FUNCTIONAL EVALUATION AND THE UNIT PERFORMED WITHIN SPECIFICATION. SERVICE DATA LOGS WERE COLLECTED FROM THE UNIT AND WERE FOUND TO BE EMPTY FOR THE CUSTOMER IDENTIFIED EVENT DATE. NO MALFUNCTION WAS CONFIRMED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED "SLOW WAKE UP TIME" AND A CONSTANT ALARM ASSOCIATED WITH THE A5 ANESTHESIA SYSTEM. CUSTOMER REPORTED THE PATIENT EXPIRED SEVERAL DAYS AFTER SURGERY IN WHICH THEY REPORTED THE SLOW WAKE UP TIME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    189270 A5 ANESTHESIA SYSTEM ANESTHESIA SYSTEM BSZ MINDRAY DS USA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Death