BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVEA VENTILATOR

    MDR report key: 6003152 · Received October 6, 2016

    Report

    Report Number
    2021710-2016-04568
    Event Type
    Injury
    Date Received
    October 6, 2016
    Date of Event
    August 27, 2016
    Report Date
    February 21, 2017
    Manufacturer
    CAREFUSION, INC
    Product Code
    CBK
    PMA / PMN Number
    K103211
    Removal / Correction Number
    Z-1609-2015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IN THE EVENT THE DEVICE IS RECEIVED FOR EVALUATION OR ADDITIONAL INFORMATION IS RECEIVED A FOLLOW-UP REPORT WILL BE SUBMITTED. AT THIS TIME, CAREFUSION HAS NOT RECEIVED THE SUSPECT DEVICE/COMPONENT FROM THE CUSTOMER FOR EVALUATION. (B)(4).

    Additional Manufacturer Narrative · 1

    THE REPORTED ISSUE OF THE SUSPECT DEVICE WAS RESOLVED BY PERFORMING REMEDIATION OF THE DEVICE UNDER FIELD CORRECTIVE ACTION. THE DEVICE HAS BEEN TESTED AND IS WORKING TO SERVICE SPECIFICATIONS. NO FURTHER INVESTIGATION WILL BE PERFORMED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE VENTILATOR ALARMED "EXT HIGH P PEAK" AND "SAFETY VALVE OPEN" DURING PATIENT USE. THE PATIENT'S OXYGEN SATURATION THEN DROPPED TO THE HIGH SEVENTIES. THE CUSTOMER STATED THERE WAS NO PERMANENT PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    653942 AVEA VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK CAREFUSION, INC AVEA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention