BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PM-8000 EXPRESS

    MDR report key: 3091165 · Received April 30, 2013

    Report

    Report Number
    2221819-2013-00907
    Event Type
    Malfunction
    Date Received
    April 30, 2013
    Date of Event
    February 25, 2013
    Report Date
    April 30, 2013
    Manufacturer
    MINDRAY DS USA, INC.
    Product Code
    MHX
    PMA / PMN Number
    070791
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    SVC REPS REPLACED THE SPO2 PC BOARD. CALIBRATED AND SAFETY TESTED UNIT TO FACTORY SPECIFICATIONS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE PM-8000 MONITOR DISPLAYED SPO2 COMMUNICATION ERROR. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    187918 PM-8000 EXPRESS PATIENT MONITOR MHX MINDRAY DS USA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1