BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRAGER VN500 VENTILATOR

    MDR report key: 6854420 · Received September 11, 2017

    Report

    Report Number
    MW5072069
    Event Type
    Injury
    Date Received
    September 11, 2017
    Date of Event
    August 8, 2017
    Report Date
    September 1, 2017
    Manufacturer
    DRAEGER, INC.
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    S5 SIPAP WAS CALIBRATED AND PLACED IN USE ON PT. TWO HOURS INTO USE, SIPAP ALARMED WITH ERROR CODE AND SHUT DOWN. PT "BAGGED" BY RN UNTIL RESPIRATORY THERAPY BROUGHT A NEW VENTILATOR. VENDOR EVALUATED VENTILATOR BUT DID NOT FIND CAUSE. M16 BOARD WAS REPLACED AND FUNCTION TESTS WERE COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    634282 DRAGER VN500 VENTILATOR INTENSIVE CARE VENTILATOR CBK DRAEGER, INC. VN500

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA Required Intervention