BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 3912436 · Received May 14, 2014

    Report

    Report Number
    8020893-2014-01163
    Event Type
    Malfunction
    Date Received
    May 14, 2014
    Date of Event
    January 1, 2014
    Report Date
    March 10, 2014
    Manufacturer
    COVIDIEN, FORMERLY NELLCOR
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COVIDIEN TECHNICAL SUPPORT ENGINEER (TSE) TROUBLESHOT THE ISSUE WITH THE CUSTOMER OVER THE PHONE. THE CUSTOMER WAS ADVISED TO REPLACE THE BREATH DELIVERY (BD) PRINTED CIRCUIT BOARD (PCB). COVIDIEN WAS NOT AUTHORIZED TO SERVICE THE DEVICE.

    Description of Event or Problem · 1

    COVIDIEN RECEIVED INFORMATION OF VENTILATOR BECOMING INOPERATIVE. THE MALFUNCTION DID NOT OCCUR DURING PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288285 840 VENTILATOR CBK COVIDIEN, FORMERLY NELLCOR 840

    Patients

    Seq Age Sex Outcome Treatment
    1