BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GAS MODULE III

    MDR report key: 3091060 · Received April 30, 2013

    Report

    Report Number
    2221819-2013-00806
    Event Type
    Malfunction
    Date Received
    April 30, 2013
    Date of Event
    March 22, 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
    GA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE REPS REPLACED THE UNITS SMALL DIAMETER TUBING BETWEEN THE O2 FILTER AND THE O2 SENSOR. PERFORMED THE RECOMMENDED 12 AND 24 MONTH PREVENTIVE MAINTENANCE. TESTED, CALIBRATED AND SAFETY CHECKED UNIT TO FACTORY SPECS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED AN ISSUE WITH THE SPECTRUM MONITOR WHICH MAY HAVE IMPACTED CO2 MONITORING. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    188180 GAS MODULE III PATIENT MONITOR BZK MINDRAY DS USA, INC

    Patients

    Seq Age Sex Outcome Treatment
    1