BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVITA XL

    MDR report key: 2901308 · Received December 14, 2012

    Report

    Report Number
    9611500-2012-00090
    Event Type
    Injury
    Date Received
    December 14, 2012
    Date of Event
    April 5, 2012
    Report Date
    December 14, 2012
    Manufacturer
    DRAEGER MEDICAL GMBH
    Product Code
    CBK
    PMA / PMN Number
    K961687
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE CHECK WAS PERFORMED ON SITE AND IT WAS VERIFIED THAT ALL ALARMS WERE FUNCTIONAL. THE LOG FILES WERE DOWNLOADED AND ANALYZED BY THE MANUFACTURER. THE LOGBOOK ANALYSIS REVEALED THAT THE EVITA XL HAS RECOGNIZED THE CHANGE OF VENTILATION CONDITIONS AND POSTED SEVERAL APPROPRIATE ALARMS DURING THE TIME OF THIS EVENT. THE EVITA XL IS DESIGNED FIRST TO COMPENSATE LEAKS AS LONG AS THE LOSS OF VOLUME IS NOT TOO MUCH. AS FOR THIS COMPENSATION THE DELIVERED VOLUME IS INCREASED, ALSO "TIDAL VOLUME HIGH" ALARM CAN BE GENERATED. THE LOGBOOK ANALYSIS SHOWS THAT ALSO ALARMS FOR "AIRWAY PRESSURE LOW" AND "APNEA" WERE POSTED DURING THE TIME OF THE LEAKAGE CONDITION. ALL ALARMS, THEIR POSSIBLE CAUSES AND REMEDIAL MEASURES ARE DESCRIBED IN THE INSTRUCTIONS FOR USE. THE MANUFACTURER COMES TO THE CONCLUSION THAT THE EVITA XL BEHAVED AS SPECIFIED DURING THE REPORTED EVENT. NO DEVICE FAILURE WAS IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE VENTILATOR DID NOT NOTIFY THE STAFF THAT THE PATIENT CIRCUIT BECAME DISCONNECTED FROM THE VENTILATOR. ACOUSTICAL ALARM WAS GENERATED, BUT THE STAFF REPORTED THAT A VISUAL "TIDAL VOLUME HIGH" ALARM WAS DISPLAYED AND NOT AN "AIRWAY PRESSURE LOW" ALARM. THE PATIENT ALLEGEDLY SUSTAINED HYPOXIC BRAIN INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EVITA XL CRITICAL CARE VENTILATOR CBK DRAEGER MEDICAL GMBH NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability