BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DPM 5 MONITOR

    MDR report key: 3091522 · Received April 30, 2013

    Report

    Report Number
    2221819-2013-00332
    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
    070791
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REP CALIBRATED AND SAFETY TESTED UNIT TO FACTORY SPECS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED AN ISSUE WITH THE DPM 5 MONITOR, WHICH MAY HAVE RESULTED IN A LOSS OF CO2 MONITORING. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    186418 DPM 5 MONITOR PATIENT MONITOR MHX MINDRAY DS USA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1