BEUDAMED
    FDA Adverse Event Summary report: N

    INFINITY ACS WORKSTATION VN500

    MDR report key: 2840020 · Received November 15, 2012

    Report

    Report Number
    9611500-2012-00078
    Date Received
    November 15, 2012
    Date of Event
    April 9, 2012
    Manufacturer
    DRAGER MEDICAL GMBH
    Product Code
    CBK
    PMA / PMN Number
    K093632
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    DESPITE REQUEST AND ADDITIONAL REMINDER, NEITHER THE REPLACED VALVE DRIVE NOR THE LOGBOOKS WERE AVAILABLE FOR EVAL. BASED ON THE GIVEN INFO, A FAILURE OF THE EXPIRATION VALVE'S DRIVE WAS IDENTIFIED BY THE TSR AS ROOT CAUSE OF THE REPORTED EVENT. IN THIS CASE, THE VENTILATOR WILL LEAK PT APPLIED GAS VIA THE EXPIRATION VALVE. THE DEVICE WILL DETECT THE DIFFERENCE BETWEEN APPLIED VOLUME AND EXHAUSTED VOLUME AND GENERATE AN ALARM. THE REPLACEMENT OF THE VALVE DRIVE FIXED THE REPORTED SYSTEM. IT'S FAILURE RATE WAS RATED TO BE ACCEPTABLE.

    Description of Event or Problem · 1

    THIS MDR IS FILED AS RESPONSE TO UFR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFINITY ACS WORKSTATION VN500 VENTILATOR, INTENSIVE CARE CBK DRAGER MEDICAL GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1