BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PASSPOR V MONITOR

    MDR report key: 4090105 · Received August 18, 2014

    Report

    Report Number
    2221819-2014-00491
    Event Type
    Malfunction
    Date Received
    August 18, 2014
    Date of Event
    July 10, 2014
    Report Date
    July 10, 2014
    Manufacturer
    MINDRAY DS USA, INC.
    Product Code
    MHX
    PMA / PMN Number
    091834
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    COMPANY REPRESENTATIVE EVALUATED THE UNIT. CORRECTIONS INCLUDED REPLACEMENTS OF THE UNIT'S CO2 BOARD. UNIT WAS CALIBRATED AND SAFETY TESTED TO FACTORY'S SPECIFICATIONS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED AN ISSUE WITH THE PASSPORT V MONITOR, WHICH MAY HAVE AFFECTED CO2 MONITORING. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    496400 PASSPOR V MONITOR PATIENT MONITOR MHX MINDRAY DS USA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1