BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 3962613 · Received June 18, 2014

    Report

    Report Number
    8020893-2014-01469
    Event Type
    Malfunction
    Date Received
    June 18, 2014
    Date of Event
    December 1, 2013
    Report Date
    January 16, 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
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COVIDIEN CUSTOMER SUPPORT ENGINEER (CSE) VERIFIED THE MALFUNCTION. THE CSE INSPECTED THE DEVICE AND REPLACED THE BREATH DELIVERY UNIT (BDU) PRINTED CIRCUIT BOARD (PCB). THE CSE UPGRADED THE SOFTWARE TO THE CURRENT REVISION AND PERFORMED THE EXTENDED SELF-TEST (EST), SHORT SELF-TEST (SST) AND THE PERFORMANCE VERIFICATION TEST (PVT); THE DEVICE OPERATED WITHIN THE MANUFACTURING SPECIFICATIONS. (B)(4).

    Description of Event or Problem · 1

    A REPORT RECEIVED FROM THE USA STATED AN 840 VENTILATOR EXPERIENCED A DEVICE ALERT WHICH RENDERED THE VENTILATOR INOPERABLE. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    356898 840 VENTILATOR CBK COVIDIEN, FORMERLY NELLCOR PURITAN 840

    Patients

    Seq Age Sex Outcome Treatment
    1