BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 3896554 · Received May 19, 2014

    Report

    Report Number
    8020893-2014-01178
    Event Type
    Malfunction
    Date Received
    May 19, 2014
    Date of Event
    December 20, 2013
    Report Date
    January 20, 2014
    Manufacturer
    COVIDIEN, FORMERLY NELLCOR
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A COVIDIEN CUSTOMER SUPPORT ENGINEER (CSE) INSPECTED THE DEVICE AND VERIFIED THE MALFUNCTION. THE CSE REPLACED THE ANALOG INTERFACE (AI) PRINTED CIRCUIT BOARD (PCB) AND PERFORMED EXTENDED SELF-TESTING ON THE DEVICE AND ALL TESTS PASSED. COVIDIEN REF: (B)(4).

    Additional Manufacturer Narrative · 1

    THE RETURNED ANALOG INTERFACE PCB (AI PCB) WAS RECEIVED FOR INVESTIGATION. THE AI PCB WAS ATTACHED TO A TEST VENTILATOR AND THE VENTILATOR FAILED TO POWER UP CORRECTLY. THE PROBLEM WAS ISOLATED TO THE CAPACITOR, THE CAPACITOR WAS REPLACED AND THIS CORRECTED THE ISSUE. THE REPORTED CUSTOMER COMPLAINT WAS VERIFIED. (B)(4).

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED FROM THAILAND STATING THAT AN 840 VENTILATOR GENERATED ERROR CODES THAT RENDERED IT INOPERABLE. THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME THAT THE MALFUNCTION OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297824 840 VENTILATOR CBK COVIDIEN, FORMERLY NELLCOR 840

    Patients

    Seq Age Sex Outcome Treatment
    1