BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 4123421 · Received September 26, 2014

    Report

    Report Number
    8020893-2014-02267
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    September 7, 2014
    Report Date
    September 11, 2014
    Manufacturer
    COVIDIEN
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER SUPPORT ENGINEER (CSE) EVALUATED THE DEVICE AND VERIFIED THE REPORTED ISSUE. THE CSE REPLACED THE POWER SUPPLY, WHICH RESOLVED THE REPORTED ISSUE.(B)(4).

    Description of Event or Problem · 1

    COVIDIEN RECEIVED INFORMATION THAT, DURING PATIENT USE, THE VENTILATOR'S DISPLAY WENT BLANK. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND PLACED ON AN ALTERNATE VENTILATOR. THE PATIENT WAS NOT HARMED OR INJURED AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602307 840 VENTILATOR CONTINUOUS VENTILATOR CBK COVIDIEN 4-840220DRAC-GR

    Patients

    Seq Age Sex Outcome Treatment
    1