BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PASSPORT V MONITOR

    MDR report key: 3091855 · Received April 30, 2013

    Report

    Report Number
    2221819-2013-00976
    Event Type
    Malfunction
    Date Received
    April 30, 2013
    Date of Event
    April 10, 2013
    Report Date
    April 30, 2013
    Manufacturer
    MINDRAY DS USA, INC.
    Product Code
    MHX
    PMA / PMN Number
    091834
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    COMPANY REPRESENTATIVE EVALUATED THE UNIT. CORRECTIONS INCLUDED REPLACEMENT OF ALL ECG CABLES, ELECTRODES, AND FILTERS AND THE PROBLEM RESOLVED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED AN ISSUE WITH THE PASSPORT V MONITOR ECG TRACES, WHICH MAY HAVE AFFECTED ECG MONITORING. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    187645 PASSPORT V MONITOR PATIENT MONITOR MHX MINDRAY DS USA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1