BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 3902546 · Received May 8, 2014

    Report

    Report Number
    8020893-2014-01140
    Event Type
    Malfunction
    Date Received
    May 8, 2014
    Report Date
    April 16, 2014
    Manufacturer
    COVIDIEN, FORMERLY NELLCOR
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    A COVIDIEN TECHNICAL SUPPORT ENGINEER (TSE) TROUBLESHOT THIS ISSUE WITH THE CUSTOMER OVER THE PHONE. TSE RECOMMENDED RESEATING THE GUI CABLE AND RUNNING THE GROUND ISOLATION TEST. THE CUSTOMER PERFORMED THIS AND THEN RAN THE GROUND ISOLATION TEST AND EXTENDED SELF TEST (EST). ALL TESTS PASSED. THE CUSTOMER REPORTED THAT NO PARTS WERE REPLACED. (B)(4).

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED FROM THE USA STATING THAT AN 840 VENTILATOR HAD A LOSS OF COMMUNICATION BETWEEN THE GRAPHIC USER INTERFACE (GUI) AND THE BREATH DELIVERY UNIT (BDU). THE VENTILATOR WAS NOT IN USE ON A PT AT THE TIME THAT THE MALFUNCTION OCCURRED. THE DATE OF THE EVENT IS UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279722 840 VENTILATOR CBK COVIDIEN, FORMERLY NELLCOR 840

    Patients

    Seq Age Sex Outcome Treatment
    1