BEUDAMED
    FDA Adverse Event Injury Summary report: N

    840 VENTILATOR

    MDR report key: 4113297 · Received September 15, 2014

    Report

    Report Number
    8020893-2014-02201
    Event Type
    Injury
    Date Received
    September 15, 2014
    Date of Event
    January 1, 2014
    Report Date
    August 21, 2014
    Manufacturer
    COVIDIEN
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COVIDIEN CUSTOMER SUPPORT ENGINEER (CSE) INSPECTED THE DEVICE AND FOUND AN ERROR CODE IN THE DIAGNOSTIC LOG, INDICATING THE BREATH DELIVERY UNIT (BDU) PRINTED CIRCUIT BOARD (PCB) NEEDED REPAIR. THE CUSTOMER DECLINED REPAIR OF THE DEVICE. (B)(4).

    Description of Event or Problem · 1

    COVIDIEN RECEIVED INFORMATION STATING THAT A VENTILATOR HAD A BLANK LOWER DISPLAY. THE MALFUNCTION OCCURRED DURING PATIENT USE. THERE NO REPORT OF PATIENT HARM OR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569467 840 VENTILATOR CONTINUOUS VENTILATOR CBK COVIDIEN 840

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention