BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PM-8000

    MDR report key: 3091167 · Received April 30, 2013

    Report

    Report Number
    2221819-2013-00902
    Event Type
    Malfunction
    Date Received
    April 30, 2013
    Date of Event
    February 28, 2013
    Report Date
    April 30, 2015
    Manufacturer
    MINDRAY DS USA, INC.
    Product Code
    MHX
    PMA / PMN Number
    070791
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    SVC REP REPLACED THE CO2 MODULE. CALIBRATED AND SAFETY TESTED UNIT TO FACTORY SPECIFICATIONS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED AN ISSUE WITH THE PM-8000 MONITOR CO2 FUNCTION WHICH MAY HAVE IMPACTED CO2 MONITORING. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    187913 PM-8000 PATIENT MONITOR MHX MINDRAY DS USA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1