BEUDAMED
    FDA Adverse Event Injury Summary report: N

    840 VENTILATOR

    MDR report key: 3780673 · Received April 18, 2014

    Report

    Report Number
    8020893-2014-00953
    Event Type
    Injury
    Date Received
    April 18, 2014
    Report Date
    March 21, 2014
    Manufacturer
    COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT IRELAND
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    A COVIDIEN CUSTOMER SUPPORT ENGINEER (CSE) VERIFIED THE MALFUNCTION. THE CSE INSPECTED THE DEVICE AND REPLACED THE PROPORTIONAL SOLENOID (PSOL) VALVE. THE DEVICE PASSED ALL TESTING ACCORDING TO MANUFACTURING SPECIFICATIONS. (B)(4).

    Description of Event or Problem · 1

    A REPORT RECEIVED FROM THE USA STATED AN 840 VENTILATOR EXPERIENCED A DEVICE ALERT WHICH RENDERED THE VENTILATOR INOPERABLE, WHILE BEING USED ON A PATIENT. THERE WAS NO REPORTED PATIENT INJURIES AS A RESULT OF THE EVENT. THE DATE OF THE EVENT IS UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238878 840 VENTILATOR CBK CBK COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT IRELAND 840

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention