BEUDAMED
    FDA Adverse Event Injury Summary report: N

    840 VENTILATOR

    MDR report key: 4222855 · Received November 4, 2014

    Report

    Report Number
    8020893-2014-02437
    Event Type
    Injury
    Date Received
    November 4, 2014
    Report Date
    October 28, 2014
    Manufacturer
    COVIDIEN
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED TO HAVE TROUBLESHOT THE ISSUE WITH A COVIDIEN TECHNICAL SUPPORT ENGINEER (TSE). THE TSE RECOMMENDED REPLACING THE OXYGEN SENSOR. THE CUSTOMER REPORTED TO HAVE REPLACED THE OXYGEN SENSOR, WHICH RESOLVED THE ISSUE. THE UNIT PASSED ALL TESTS AND CALIBRATIONS, AND IT WAS OBSERVED TO BE OPERATING WITHIN MANUFACTURING SPECIFICATIONS. THE DEVICE HAS BEEN RETURNED TO PATIENT USE, AND NO FURTHER ASSISTANCE IS REQUIRED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY A CUSTOMER IN THE USA THAT, DURING PATIENT USE, THE 840 VENTILATOR GENERATED AN ERROR MESSAGE OF "INSUFFICIENT O2 SUPPLY". THE PATIENT WAS REMOVED FROM THE VENTILATOR, MANUALLY VENTILATED AND PLACED ON AN ALTERNATE VENTILATOR. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    707574 840 VENTILATOR CONTINUOUS VENTILATOR CBK COVIDIEN 840

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention