BEUDAMED
    FDA Adverse Event Other Summary report: N

    EVITA

    MDR report key: 1662777 · Received April 9, 2010

    Report

    Report Number
    9611500-2010-00015
    Event Type
    Other
    Date Received
    April 9, 2010
    Report Date
    April 9, 2010
    Manufacturer
    DRAEGER MEDICAL AG & CO. KG
    Product Code
    CBK
    PMA / PMN Number
    K961687
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT IS NOT CAUSED OR RELATED TO A TECHNICAL FAULT OF THE VENTILATOR. THE VENTILATOR PERFORMED AND ALARMED ACCORDING TO SPEC. THE APPROPRIATE ALARMS HAVE BEEN VERIFIED BY ANALYSIS OF THE DEVICE LOG FILE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE VENTILATING A PT NURSING CARE WAS BEING PROVIDED WITH THE PT. NURSING SILENCED THE ALARM SEVERAL TIMES. AT SOME POINT, THE INSPIRATORY LIMB OF THE CIRCUIT BECAME DISCONNECTED FROM THE FISHER & PAYKEL HUMIDIFIER CANISTER AND THE PT CODED (RESPIRATORY/CARDIAC ARREST) BUT WAS REVIVED. A RESPIRATORY THERAPIST RESPONDED TO THE ROOM AND RECONNECTED THE CIRCUIT. NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EVITA CONTINUOUS VENTILATOR CBK DRAEGER MEDICAL AG & CO. KG

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention