BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 3853596 · Received April 3, 2014

    Report

    Report Number
    8020893-2014-00774
    Event Type
    Malfunction
    Date Received
    April 3, 2014
    Report Date
    March 5, 2014
    Manufacturer
    COVIDIEN, FORMERLY NELLCOR PURITAN
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COVIDIEN CUSTOMER SUPPORT ENGINEER (CSE) INSPECTED THE DEVICE AND VERIFIED THE REPORTED ISSUE. THE CSE REPLACED THE GRAPHICAL USER INTERFACE (GUI) TOUCH FRAME, PRINTED CIRCUIT BOARD (PCB). THE DEVICE PASSED ALL CALIBRATIONS, SHORT SELF-TEST, EXTENDED SELF-TEST (EST) AND PERFORMANCE VERIFICATION TEST ACCORDING TO MFR SPECS. (B)(4).

    Description of Event or Problem · 1

    A REPORT RECEIVED FROM THE USA STATED AN 840 VENTILATOR EXPERIENCED AN UNRESPONSIVE TOUCHSCREEN. THE VENTILATOR WAS NOT IN USE ON A PT AT THE TIME OF THE EVENT. THE DATE OF THE EVENT IS UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202596 840 VENTILATOR CBK COVIDIEN, FORMERLY NELLCOR PURITAN 840

    Patients

    Seq Age Sex Outcome Treatment
    1