BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BENEVIEW MONITOR

    MDR report key: 3091670 · Received April 30, 2013

    Report

    Report Number
    2221819-2013-00639
    Event Type
    Malfunction
    Date Received
    April 30, 2013
    Date of Event
    October 28, 2011
    Report Date
    April 30, 2013
    Manufacturer
    SHENZHEN BIOMEDICAL ELECTRONICS CO
    Product Code
    DSI
    PMA / PMN Number
    092449
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED A FAILED CO2 MODULE ON THE BENEVIEW MONITOR. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    187731 BENEVIEW MONITOR PATIENT MONITOR DSI SHENZHEN BIOMEDICAL ELECTRONICS CO

    Patients

    Seq Age Sex Outcome Treatment
    1