BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 2110008 · Received April 28, 2011

    Report

    Report Number
    8020893-2011-00209
    Event Type
    Malfunction
    Date Received
    April 28, 2011
    Date of Event
    March 29, 2011
    Report Date
    March 29, 2011
    Manufacturer
    COVIDIEN, FORMERLY NELLCOR
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    COVIDIEN RECEIVED INFORMATION ALLEGING THAT THE VENTILATOR POWERED DOWN AND IMMEDIATELY POWERED BACK UP WHILE IN USE. THERE WAS NO PATIENT HARM OR INJURY REPORTED. AS PER HOSPITAL VENTILATOR ALARMED. THE CUSTOMER SERVICE ENGINEER (CSE) INSPECTED THE DEVICE, REPLACED THE ANALOG INTERFACE PCB AND THE POWER SWITCH AS PRECAUTIONARY. FAILURE INVESTIGATION IS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 840 VENTILATOR VENTILATOR CBK COVIDIEN, FORMERLY NELLCOR 840

    Patients

    Seq Age Sex Outcome Treatment
    1