BEUDAMED
    FDA Adverse Event Death Summary report: N

    MILLENNIUM INFANT VENTILATOR

    MDR report key: 2194539 · Received August 1, 2011

    Report

    Report Number
    2020676-2011-00006
    Event Type
    Death
    Date Received
    August 1, 2011
    Date of Event
    July 28, 2010
    Report Date
    July 28, 2011
    Manufacturer
    SECHRIST INDUSTRIES, INC.
    Product Code
    CBK
    PMA / PMN Number
    K993167
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PT INFO OR EXACT DATE OF INCIDENT PROVIDED. ATTEMPTING TO OBTAIN FURTHER INFO ON THE REPORTED EVENT. WILL PROVIDE UPDATE IN F/U ONCE INFO IS REC'D.

    Description of Event or Problem · 1

    THE DISTRIBUTOR REPORTED A PROBLEM WITH A VENTILATOR DURING CLINICAL USE VIA EMAIL. THE DETAILS OF THE REPORTED INCIDENT FOUND A STATEMENT MADE BY THE TECHNICAL VENTILATOR THERAPIST AT THE HOSP THAT STATED REPORTED DEATH OCCURRED LAST YEAR AND WAS ASSOCIATED TO THE SAME VENTILATOR. A SEARCH OF OUR COMPLAINT RECORDS CONCERNING THIS DEVICE AND OTHERS ASSOCIATED WITH THE HOSP DID NOT FIND A REPORTED CLINICAL INCIDENT INVOLVING THIS OR OTHER DEVICES. THE DISTRIBUTOR WAS CONTACTED AND ASKED FOR DETAILS CONCERNING THE REPORTED DEATH. THE DISTRIBUTOR WAS NOT MADE AWARE OF THE REPORTED DATE UNTIL (B)(6) 2011. THE DISTRIBUTOR'S ENGINEER WAS AT THE HOSP TO FIND OUT MORE INFO REGARDING THE RECENT REPORTED EVENT AND THE REPORTED DEATH. THERE IS NO RECORD OF THE REPORTED DEATH AND NO SPECIFIC DATE ON WHEN IT OCCURRED. THE BEST GUESS BASED ON THE TECHNICAL VENTILATOR THERAPIST STATEMENTS IS THE DEATH OCCURRED AROUND (B)(6) 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MILLENNIUM INFANT VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK SECHRIST INDUSTRIES, INC. 23065-2

    Patients

    Seq Age Sex Outcome Treatment
    1 Death