BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 2243823 · Received August 24, 2011

    Report

    Report Number
    8020893-2011-00367
    Event Type
    Malfunction
    Date Received
    August 24, 2011
    Date of Event
    July 23, 2011
    Report Date
    July 28, 2011
    Manufacturer
    COVIDIEN, FORMERLY NELLCOR
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MULTIPLE ATTEMPTS TO CUSTOMER HAVE BEEN MADE WITH NO CUSTOMER RESPONSE. IF THE CUSTOMER REPORTS FURTHER INFO, THE COMPLAINT RECORD WILL BE RE-OPENED.

    Description of Event or Problem · 1

    THE SERVICE REPORT SHOWS THE CUSTOMER REPORTED THAT THE 840 VENTILATOR MALFUNCTIONED WHILE IN USE ON A PT. THE PT WAS NOT HARMED OR INJURED AS A RESULT OF THE EVENT. THE PURITAN BENNETT CUSTOMER SUPPORT ENGINEER (CSE) INSPECTED THE DEVICE AND COULD NOT DUPLICATE THE REPORTED FAILURE. THE UNIT PASSED EXTENDED SELF TESTING.

    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