BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GAS MODULE III

    MDR report key: 3091458 · Received April 30, 2013

    Report

    Report Number
    2221819-2013-00361
    Event Type
    Malfunction
    Date Received
    April 30, 2013
    Date of Event
    August 30, 2012
    Report Date
    April 30, 2013
    Manufacturer
    MINDRAY DS USA, INC.
    Product Code
    BZK
    PMA / PMN Number
    062754
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REP EVALUATED THE UNIT. CORRECTIONS INCLUDED REPLACEMENT OF THE PUMP, EXHAUST HOSE, AND TUBING BETWEEN THE O2 FILTER AND THE O2 SENSOR. PERFORMED GAS CALIBRATION AND TESTED TO FACTORY'S SPECIFICATIONS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A GAS MODULE III GAS FLOW WAS OUT OF SPECIFICATION AND THE EXHAUST WAS BLOCKED WHICH MAY HAVE IMPACTED GAS MONITORING. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    186682 GAS MODULE III GAS MODULE BZK MINDRAY DS USA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1