BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MILLENNIUM INFANT VENTILATOR

    MDR report key: 2801580 · Received October 18, 2012

    Report

    Report Number
    2020676-2012-00041
    Event Type
    Malfunction
    Date Received
    October 18, 2012
    Date of Event
    September 19, 2012
    Report Date
    October 18, 2012
    Manufacturer
    SECHRIST INDUSTRIES, INC.
    Product Code
    CBK
    PMA / PMN Number
    K993167
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DISTRIBUTOR HAS BEEN CONTACTED THREE TIMES IN AN ATTEMPT TO OBTAIN INFORMATION REGARDING WHEN THE EVENT OCCURRED, SERIAL NUMBER OF THE DEVICE, IF THERE WAS PATIENT INVOLVEMENT AND TO VERIFY THAT THE DEVICE HAS BEEN REPAIRED AND BROUGHT BACK TO FUNCTIONING PER FACTORY STANDARDS. THE MANUFACTURER WAS NOTIFIED BY THE DISTRIBUTOR THAT THE INFORMATION IS FORTHCOMING. AS OF THE TIME OF THIS REPORT WAS COMPLETED THE REQUESTED INFORMATION HAS NOT BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH THE EVENT INFORMATION PROVIDED BY THE DISTRIBUTOR ONCE IT HAS BEEN RECEIVED BY THE MANUFACTURER.

    Description of Event or Problem · 1

    THE DISTRIBUTOR CONTACTED THE MANUFACTURER VIA EMAIL AND STATED THAT A MILLENNIUM VENTILATOR WAS SHOWING ERROR MESSAGE ¿A01 LOW, LOSS OF INLET GAS¿ WHEN THE FIO2 IS SET TO ANYTHING ABOVE 70. TECHNICAL ASSISTANCE WAS PROVIDED TO THE DISTRIBUTOR AND THE FOLLOWING INFORMATION WAS REPORTED BACK TO THE MANUFACTURER: AFTER REMOVING BOTH FILTERS, AIR AND OXYGEN, AND AFTER INSTALLING ONE SIDE ONLY AND SWAPPING THE PROCESS, IT APPEARED THAT THE PROBLEM WAS WITH THE OXYGEN FILTER AND NOT THE AIR. REVIEW OF THIS COMPLAINT BY THE TECHNICAL SERVICES DEPARTMENT DETERMINED THAT THE OXYGEN FILTER HAD BEEN CLOGGED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1