BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PASSPORT 2 MONITOR

    MDR report key: 3091333 · Received April 30, 2013

    Report

    Report Number
    2221819-2013-00993
    Event Type
    Malfunction
    Date Received
    April 30, 2013
    Date of Event
    October 16, 2012
    Report Date
    April 30, 2013
    Manufacturer
    MINDRAY DS USA, INC.
    Product Code
    MHX
    PMA / PMN Number
    020550
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    COMPANY REP EVALUATED THE UNIT. CORRECTIONS INCLUDED REPLACEMENT OF THE DATASETTE AND RESEATING THE CABLES. UNIT WAS CALIBRATED AND SAFETY TESTED TO FACTORY SPECIFICATIONS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE PASSPORT 2 MONITOR SHUTS OFF INTERMITTENTLY, WHICH MAY HAVE AFFECTED PT MONITORING. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    186888 PASSPORT 2 MONITOR PATIENT MONITOR MHX MINDRAY DS USA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1