BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GAS MODULE III

    MDR report key: 3091505 · Received April 30, 2013

    Report

    Report Number
    2221819-2013-00344
    Event Type
    Malfunction
    Date Received
    April 30, 2013
    Date of Event
    August 20, 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
    IL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REPRESENTATIVE EVALUATED THE UNIT AND FOUND THAT THE UNIT WOULD NOT CALIBRATE. THE CUSTOMER WAS INFORMED THE GAS BENCH NEEDED TO BE REPLACED, BUT DECLINED REPAIR.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE GAS MODULE III HAD INACCURATE O2 READINGS. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    186754 GAS MODULE III GAS MODULE BZK MINDRAY DS USA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1