BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 3853468 · Received April 4, 2014

    Report

    Report Number
    8020893-2014-00816
    Event Type
    Malfunction
    Date Received
    April 4, 2014
    Date of Event
    January 10, 2014
    Report Date
    January 10, 2014
    Manufacturer
    COVIDIEN, FORMERLY NELLCOR PURITAN
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COVIDIEN CUSTOMER SUPPORT ENGINEER (CSE) INSPECTED THE DEVICE AND VERIFIED THE CUSTOMER REPORT ISSUE. THE CSE REPLACED THE GRAPHIC USER INTERFACE (GUI), CENTRAL PROCESSING UNIT (CPU), PRINTED CIRCUIT BOARD (PCB), WHICH RESOLVED THE CUSTOMER REPORTED ISSUE. THE VENTILATOR PASSED EXTENDED SELF-TESTING. COVIDIEN REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE VENTILATOR HAD AN ERRATIC DISPLAY. THE MALFUNCTION DID NOT OCCUR DURING PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203678 840 VENTILATOR CBK: VENTILATOR, CONTINUOUS, FACILITY CBK COVIDIEN, FORMERLY NELLCOR PURITAN 840

    Patients

    Seq Age Sex Outcome Treatment
    1