BEUDAMED
    FDA Adverse Event Injury Summary report: N

    840 VENTILATOR

    MDR report key: 4200759 · Received October 24, 2014

    Report

    Report Number
    8020893-2014-02398
    Event Type
    Injury
    Date Received
    October 24, 2014
    Report Date
    October 7, 2014
    Manufacturer
    COVIDIEN
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER INFORMED TO HAVE REPLACED THE PROPORTIONAL SOLENOID VALVE, AND PERFORMED EXTENDED SELF-TESTING. 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.

    Additional Manufacturer Narrative · 1

    THE COVIDIEN TECHNICAL SUPPORT ENGINEER (TSE) TROUBLESHOT THE ISSUE WITH THE CUSTOMER OVER THE TELEPHONE. THE CUSTOMER WAS RECOMMENDED TO REPLACING THE AIR PROPORTIONAL SOLENOID (PSOL) VALVE, AND TO CALL BACK IF THE VENTILATOR GENERATED ANY ADDITIONAL ERROR CODES. ALTHOUGH REQUESTED, IT IS UNKNOWN IF THE VENTILATOR WAS ALREADY REPAIRED. (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 CODE ¿PSOL STUCK¿, AND BECAME INOPERATIVE. THE PATIENT WAS TRANSFERRED TO ANOTHER VENTILATOR. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679944 840 VENTILATOR CONTINUOUS VENTILATOR CBK COVIDIEN 840

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention