BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MILLENNIUM VENTILATOR

    MDR report key: 5308898 · Received December 17, 2015

    Report

    Report Number
    2020676-2015-00050
    Event Type
    Malfunction
    Date Received
    December 17, 2015
    Date of Event
    December 7, 2015
    Report Date
    December 9, 2015
    Manufacturer
    SECHRIST INDUSTRIES, INC.
    Product Code
    CBK
    PMA / PMN Number
    K993167
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS CURRENTLY UNDERWAY. ONCE COMPLETE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THE UNIT WAS TESTED PER DOCUMENTS 150009 REV. 40, 170025 REV. 36, 150127 REV. 13 AND, 170310 REV. 14. DURING THE FUNCTIONAL TEST WHEN THE INSPIRATORY PRESSURE WAS CHECKED THE MAXIMUM INSPIRATORY PRESSURE WAS 83.0 CMH20. ONCE THE INITIAL INSPECTION WAS COMPLETE THE UNIT WAS OPENED AND THE INSIDE WAS CHECKED, THE REGULATOR WAS NOT LOCKED DOWN. THE COMPLAINT IS VERIFIED. THE REGULATOR MAY NOT HAVE BEEN PUSHED DOWN ALL THE WAY BEFORE CLOSE UP. THE DEVICE WAS REPAIRED AND RETURNED TO THE CUSTOMER. THIS REPORT IS SUBMITTED TO COMPLY WITH MDR MALFUNCTION NOTICE 76 FR 12473 REQUIRING THE REPORTING OF INCIDENTS INVOLVING A LIFE-SUPPORTING AND/OR LIFE-SUSTAINING DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT," DURING PRE-USE CHECK, IT WAS FOUND THAT PRESSURE IS OUT OF SPECIFICATION." NO PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    834965 MILLENNIUM VENTILATOR INFANT VENTILATOR CBK SECHRIST INDUSTRIES, INC. 23065-1

    Patients

    Seq Age Sex Outcome Treatment
    1