BEUDAMED
    FDA Adverse Event Other Summary report: N

    V SERIES MONITOR

    MDR report key: 3150109 · Received May 31, 2013

    Report

    Report Number
    2221819-2013-01141
    Event Type
    Other
    Date Received
    May 31, 2013
    Date of Event
    April 19, 2013
    Report Date
    May 31, 2013
    Manufacturer
    MINDRAY DS USA, INC.
    Product Code
    MHX
    PMA / PMN Number
    102004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    COMPANY REP EVALUATED THE UNIT AND REPLACED THE COMMUNICATION BOARD. UNIT WAS CALIBRATED AND SAFETY TESTED TO FACTORY'S SPECIFICATIONS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE V SERIES HAD NO SPO2 READINGS. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240209 V SERIES MONITOR PATIENT MONITOR MHX MINDRAY DS USA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1