BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 1950127 · Received December 9, 2010

    Report

    Report Number
    8020893-2010-00575
    Event Type
    Malfunction
    Date Received
    December 9, 2010
    Date of Event
    December 1, 2010
    Report Date
    December 7, 2010
    Manufacturer
    PURITAN BENNETT CORP.
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    COVIDIEN TECHNICAL SUPPORT TROUBLESHOOT THE ISSUE WITH CUSTOMER OVER THE PHONE, AND RECOMMENDED TO RUN THE UNIT FOR 48 HOURS. CONTACTED HOSPITAL'S BIOMED AND HE REPORTED THAT ALLEGE MALFUNCTION COULD NOT BE DUPLICATED. COVIDIEN WAS NOT AUTHORIZED TO SERVICE THE DEVICE.

    Description of Event or Problem · 1

    THE SERVICE REPORT SHOWS THAT THE 840 VENTILATOR STOPPED CYCLING WHILE IN USE ON A PT. THE PT WAS NOT HARMED OR INJURED AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 840 VENTILATOR VENTILATOR CBK PURITAN BENNETT CORP. 840

    Patients

    Seq Age Sex Outcome Treatment
    1