BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 3894150 · Received February 6, 2014

    Report

    Report Number
    8020893-2014-00303
    Event Type
    Malfunction
    Date Received
    February 6, 2014
    Date of Event
    January 10, 2014
    Report Date
    January 10, 2014
    Manufacturer
    COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT IRELAND
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COVIDIEN CUSTOMER SUPPORT ENGINEER (CSE) INSPECTED THE DEVICE AND VERIFIED THE CUSTOMER REPORTED PROBLEM. THE CSE REPLACED THE BREATH DELIVERY UNIT (BDU) PRINTED CIRCUIT BOARD ASSEMBLY (PCBA). THE UNIT PASSED EXTENDED SELF-TESTING.

    Description of Event or Problem · 1

    COVIDIEN RECEIVED INFORMATION THAT THE VENTILATOR WAS INOPERABLE. THE MALFUNCTION DID NOT OCCUR DURING PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78618 840 VENTILATOR CBK; VENTILATOR, CONTINUOUS, FACILITY USE CBK COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT IRELAND 840

    Patients

    Seq Age Sex Outcome Treatment
    1