BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 3982947 · Received July 2, 2014

    Report

    Report Number
    8020893-2014-01539
    Event Type
    Malfunction
    Date Received
    July 2, 2014
    Date of Event
    May 28, 2014
    Report Date
    June 11, 2014
    Manufacturer
    COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT IRELAND
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COVIDIEN CUSTOMER SUPPORT ENGINEER (CSE) VERIFIED THE MALFUNCTION AND REPLACED THE ANALOG INTERFACE (AI) PRINTED CIRCUIT BOARD (PCB). THE CSE PERFORMED ALL CALIBRATIONS, THE EXTENDED SELF-TEST (EST), SHORT SELF-TEST (SST) AND THE ELECTRICAL SAFETY TEST; THE DEVICE OPERATED WITHIN THE MANUFACTURING SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    THE EVALUATION AND REPAIR OF THE DEVICE HAS NOT BEEN COMPLETED. COVIDIEN REFERENCE: (B)(4).

    Description of Event or Problem · 1

    COVIDIEN RECEIVED INFORMATION STATING THAT THE 840 VENTILATOR LOST COMMUNICATIONS. THE MALFUNCTION DID NOT OCCUR DURING PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    388382 840 VENTILATOR CBK COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT IRELAND 840

    Patients

    Seq Age Sex Outcome Treatment
    1