BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 3853472 · Received April 4, 2014

    Report

    Report Number
    8020893-2014-00820
    Event Type
    Malfunction
    Date Received
    April 4, 2014
    Date of Event
    January 13, 2014
    Report Date
    January 13, 2014
    Manufacturer
    COVIDIEN, FORMERLY NELLCOR PURITAN
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COVIDIEN CUSTOMER SUPPORT ENGINEER (CSE) INSPECTED THE DEVICE AND VERIFIED THE CUSTOMER REPORTED ISSUE. THE CSE REPLACED THE GRAPHIC USER INTERFACE (GUI) PRINTED CIRCUIT BOARD (PCB) WHICH RESOLVED THE CUSTOMER REPORTED ISSUE. THE VENTILATOR PASSED EXTENDED SELF-TESTING (EST), SHORT SELF-TESTS (SST), AND PERFORMANCE VERIFICATION TESTING (PVT). (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A VENTILATOR WITH A BLANK DISPLAY. THE MALFUNCTION DID NOT OCCUR DURING PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203563 840 VENTILATOR CBK: VENTILATOR, CONTINUOUS, FACILITY CBK COVIDIEN, FORMERLY NELLCOR PURITAN 840

    Patients

    Seq Age Sex Outcome Treatment
    1