BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTELLIVUE G5 AGM

    MDR report key: 3212767 · Received July 1, 2013

    Report

    Report Number
    9610816-2013-00144
    Event Type
    Injury
    Date Received
    July 1, 2013
    Date of Event
    June 21, 2013
    Report Date
    June 21, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K060541
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): A FOLLOW UP REPORT WILL BE SUBMITTED AFTER PHILIPS OBTAINS MORE INFO CONCERNING THIS EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO PHILIPS AN INCIDENT WITH A M1019A GAS MODULE. THE G5 WAS SHOWING TOO LOW CO2 SO THE PT RECEIVED TOO MUCH CO2 DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297840 INTELLIVUE G5 AGM MHX PHILIPS MEDICAL SYSTEMS M1019A

    Patients

    Seq Age Sex Outcome Treatment
    1