BEUDAMED
    FDA Adverse Event Injury Summary report: N

    840 VENTILATOR

    MDR report key: 3893944 · Received June 11, 2014

    Report

    Report Number
    8020893-2014-01403
    Event Type
    Injury
    Date Received
    June 11, 2014
    Date of Event
    January 1, 2014
    Report Date
    May 15, 2014
    Manufacturer
    COVIDIEN, FORMERLY NELLCOR
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COVIDIEN TECHNICAL SUPPORT ENGINEER (TSE) TROUBLESHOT THE ISSUE WITH THE CUSTOMER OVER THE TELEPHONE. THE TSE RECOMMENDED REPLACING THE AIR PROPORTIONAL SOLENOID (PSOL) VALVE. THE INVESTIGATION IS ONGOING. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY A CUSTOMER IN THE USA THAT, DURING PATIENT USE, AN 840 VENTILATOR EXHIBITED AN ERROR CODE SUGGESTING INOPERABLE CONDITION. THERE WAS NO REPORTED PATIENT INJURY. ALTHOUGH REQUEST, AT THE MOMENT, IT IS UNKNOWN IF THE PATIENT WAS TRANSFERRED TO AN ALTERNATIVE VENTILATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    346275 840 VENTILATOR CBK COVIDIEN, FORMERLY NELLCOR 840

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention