BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PASSPORT V MONITOR

    MDR report key: 3091527 · Received April 30, 2013

    Report

    Report Number
    2221819-2013-00329
    Event Type
    Malfunction
    Date Received
    April 30, 2013
    Date of Event
    August 22, 2012
    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
    MI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REP EVALUATED THE SYSTEM. CORRECTIONS INCLUDED REPLACEMENT OF THE ECG MODULE. THE UNIT WAS TESTED TO FACTORY'S SPECS. IT FUNCTIONED NORMALLY AND WAS RETURNED TO USE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE PASSPORT V MONITOR HAD AN ERROR MESSAGE, WHICH MAY HAVE NO RESULTED IN LOSS OF ECG MONITORING. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    187275 PASSPORT V MONITOR PATIENT MONITOR MHX MINDRAY DS USA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1