BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PASSPORT V AND TRIO MONITOR

    MDR report key: 3091300 · Received April 30, 2013

    Report

    Report Number
    2221819-2013-00171
    Event Type
    Malfunction
    Date Received
    April 30, 2013
    Date of Event
    January 14, 2013
    Report Date
    April 30, 2013
    Manufacturer
    MINDRAY DS USA, INC.
    Product Code
    MHX
    PMA / PMN Number
    051897
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    MINDRAY REPRESENTATIVES WERE UNABLE TO CONFIRM THE REPORTED ISSUE. PROPER OPERATION WAS VERIFIED. (WO - (B)(4)).

    Description of Event or Problem · 1

    CUSTOMER REPORTED INTERMITTENT LOSS OF THE ECG SIGNAL ON THE PASSPORT V AND TRIO MONITOR WHEN THESE MONITORS ARE USED IN ONE SPECIFIC ROOM IN THEIR FACILITY, WHICH MAY HAVE RESULTED IN A LOSS OF ECG MONITORING. NO PATIENT INJURY AS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    186884 PASSPORT V AND TRIO MONITOR PATIENT MONITOR MHX MINDRAY DS USA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1