BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GAS MODULE II

    MDR report key: 3091844 · Received April 30, 2013

    Report

    Report Number
    2221819-2013-01002
    Event Type
    Malfunction
    Date Received
    April 30, 2013
    Date of Event
    April 5, 2013
    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

    COMPANY REP REPLACED THE SMALL DIAMETER TUBING BETWEEN THE O2 FILTER AND SENSOR. ADJUSTED THE VOLT POWER SUPPLIES. TESTED, CALIBRATED AND SAFETY CHECKED UNIT TO SPECIFICATIONS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED AN ISSUE WITH THE GAS MODULE II, WHICH MAY HAVE IMPACTED GAS MONITORING. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    186443 GAS MODULE II GAS MONITOR BZK MINDRAY DS USA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1