BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 4213213 · Received August 4, 2014

    Report

    Report Number
    8020893-2014-01954
    Event Type
    Malfunction
    Date Received
    August 4, 2014
    Date of Event
    July 1, 2014
    Report Date
    July 23, 2014
    Manufacturer
    COVIDIEN
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COVIDIEN SERVICE ENGINEER (CSE) RE INSTALLED THE BREATH DELIVERY UNIT (BDU) CENTRAL PROCESSING UNIT (CPU) PRINTED CIRCUIT BOARD (PCB) AND THE CABLE BETWEEN THE BDU AND GRAPHIC USER INTERFACE (GUI) HOWEVER THE ISSUE WAS NOT RESOLVED. THE CSE THEN REPLACED THE BDU CPU PCB AND DOWNLOADED THE LATEST SOFTWARE. AFTER RUNNING THREE CALIBRATIONS THE UNIT PASSED ALL TESTING. THERE WAS NO PT INVOLVEMENT. (B)(4).

    Description of Event or Problem · 1

    COVIDIEN RECEIVED INFORMATION STATING THAT THERE WAS A SYSTEM ERROR DURING AN 840 VENTILATOR START UP. THE UNIT THEN DID NOT ENTER THE SERVICE MENU. THERE WAS NO REPORTED PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    455588 840 VENTILATOR CONTINUOUS VENTILATOR CBK COVIDIEN 840

    Patients

    Seq Age Sex Outcome Treatment
    1