BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    A5 ANESTHESIA DELIVERY SYSTEM

    MDR report key: 4090052 · Received August 18, 2014

    Report

    Report Number
    2221819-2014-00507
    Event Type
    Malfunction
    Date Received
    August 18, 2014
    Date of Event
    August 4, 2014
    Report Date
    August 11, 2014
    Manufacturer
    MINDRAY DS USA, INC.
    Product Code
    BSZ
    PMA / PMN Number
    123211
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S CONTRACTED BIOMEDICAL ENGINEERING EVALUATED THE A5 SYSTEM AND CONFIRMED THE LOW GAS READINGS. AN ISSUE WAS IDENTIFIED WITH A CRACKED TUBING THAT WAS LEAKING WHILE BEING USED TO ABSORB WATER AND TO ALLEVIATE MOISTURE. THE TUBING WAS REPLACED AND PROBLEM WAS RESOLVED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE A5 ANESTHESIA DELIVERY SYSTEM DISPLAYED AN INACCURATE (LOW) O2 AND CO2 READINGS DURING A CASE, WHICH MAY HAVE AFFECTED ANESTHESIA MONITORING. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    496245 A5 ANESTHESIA DELIVERY SYSTEM ANESTHESIA DELIVERY SYSTEM BSZ MINDRAY DS USA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1