BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITY ACS WORKSTATION NC

    MDR report key: 4749980 · Received April 24, 2015

    Report

    Report Number
    9611500-2015-00059
    Event Type
    Malfunction
    Date Received
    April 24, 2015
    Date of Event
    March 14, 2015
    Report Date
    April 24, 2015
    Manufacturer
    DRAEGER MEDICAL GMBH
    Product Code
    MSX
    PMA / PMN Number
    K093632
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION WAS STARTED BUT IS NOT YET CONCLUDED. THE INVESTIGATION RESULTS WILL BE REPORTED IN THE FOLLOW UP REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE SHUT DOWN WHILE VENTILATING A PT. NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274413 INFINITY ACS WORKSTATION NC VENTILATORS, INTENSTIVE CARE MSX DRAEGER MEDICAL GMBH NA

    Patients

    Seq Age Sex Outcome Treatment
    1