BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DPM 6 MONITOR

    MDR report key: 4122202 · Received September 18, 2014

    Report

    Report Number
    2221819-2014-00548
    Event Type
    Malfunction
    Date Received
    September 18, 2014
    Date of Event
    July 23, 2014
    Report Date
    July 30, 2014
    Manufacturer
    MINDRAY BIOMEDICAL ELECTRONICS CO. LTD
    Product Code
    MHX
    PMA / PMN Number
    092449
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    COMPANY REPRESENTATIVE EVALUATED THE UNIT. CORRECTIONS INCLUDED REPLACEMENT OF THE UNIT'S MPM MODULE FRONT PANEL. UNIT WAS CALIBRATED AND TESTED TO FACTORY'S SPECIFICATIONS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED AN ISSUE WITH THE DPM 6 MONITOR, WHICH MAY HAVE AFFECTED PATIENT MONITORING. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579061 DPM 6 MONITOR PATIENT MONITOR MHX MINDRAY BIOMEDICAL ELECTRONICS CO. LTD

    Patients

    Seq Age Sex Outcome Treatment
    1