BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 3822822 · Received February 5, 2014

    Report

    Report Number
    8020893-2014-00284
    Event Type
    Malfunction
    Date Received
    February 5, 2014
    Date of Event
    December 10, 2013
    Report Date
    December 10, 2013
    Manufacturer
    COVIDIEN, FORMERLY NELLCOR PURITAN
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COVIDIEN CUSTOMER SUPPORT ENGINEER REPLACED THE KEYBOARD, WHICH RESOLVED THE ISSUE. THE CSE COMPLETED THE SERVICE OF THE DEVICE.

    Description of Event or Problem · 1

    SERVICE REPORT SHOWS THAT THE KEYBOARD ON 840 VENTILATOR HAD AN UNRESPONSIVE KEY. THE MALFUNCTION DID NOT OCCUR DURING PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76302 840 VENTILATOR CBK: CONTINUOUS, VENTILATOR, FACILITY CBK COVIDIEN, FORMERLY NELLCOR PURITAN 840

    Patients

    Seq Age Sex Outcome Treatment
    1