BEUDAMED
    FDA Adverse Event Other Summary report: N

    MILLENNIUM INFANT VENTILATOR

    MDR report key: 3099545 · Received May 3, 2013

    Report

    Report Number
    2020676-2013-00011
    Event Type
    Other
    Date Received
    May 3, 2013
    Date of Event
    March 24, 2013
    Report Date
    May 3, 2013
    Manufacturer
    SECHRIST INDUSTRIES, INC.
    Product Code
    CBK
    PMA / PMN Number
    K993167
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE VENTILATOR WAS SENT TO AND RECEIVED BY THE MANUFACTURER FOR EVALUATION. IT ARRIVED IN A BOX WITH INSUFFICIENT PACKAGING THAT ALLOWED DAMAGE TO OCCUR TO THE UNIT. THE BACK ENCLOSURE IS DAMAGED AND PAIN IS CHIPPED BY THE ALARM DELAY BUTTON. THE VENTILATOR WAS TESTED AS IT WAS RECEIVED. THE FLOW METER WAS SHUT OFF, MIXER SET AT 28.5 FIO2, LOW PEEP/BASELINE PRESSURE ALARM SET AT 5 CMH2O, UNIT IN STANDBY, AND SENSITIVITY SETTING AT 1 BAR. THERE WERE NO ALARM SELECT INDICATORS SHOWING. AFTER SETTING THE UNIT TO DEFAULT THE ALARM SELECT INDICATORS DISPLAYED. ORIGINALLY "BLANK" MAY HAVE BEEN SELECTED. TESTING OF THE MIXER INSIDE THE VENTILATOR FOUND THAT THE FIO2 IS OUT AT .30 FIO2. THE BLEED FLOW WAS NOT TESTED DUE TO THE UNIT BEING TESTED AS RECEIVED. TESTING OF THE VENTILATOR FOUND THE MAXIMUM INSPIRATORY PRESSURE, MAXIMUM EXHALATION PRESSURE, AND INTERACTION ARE OUT OF SPECIFICATION. EVALUATION OF THE INTERIOR OF THE VENTILATOR WAS COMPLETED AFTER FUNCTIONAL TESTING. THE CASE SCREWS ARE NOT TIGHT, THE SCREWS ARE LOOSE ON THE BACK PLATE AND/OR HAVE COME OUT OF THE UNIT, AND THE NEEDLE VALVE ON THE NON-FLUIDIC MANIFOLD HAS BEEN TURNED. THE TAMPER PROOF ELEMENT HAS COME OFF SHOWING SIGNS OF ADJUSTMENT. THE IMMEDIATE CAUSE OF THE MIXER BEING OUT OF SPECIFICATION IS TOLERANCE STACK-UP AND/OR OPERATOR ERROR. DURING MANUFACTURING THE KNOB MAY HAVE BEEN INSTALLED SLIGHTLY OFF-CENTER. THE IMMEDIATE CAUSE OF THE INTERACTION IN THE VENTILATOR IS DETERIORATION OF THE DUCKBILL. THE ROOT CAUSE IS FAILURE TO FOLLOW INSTRUCTIONS FOR USE. IT IS RECOMMENDED THAT THE VENTILATOR BE OVERHAULED EVERY 2 YEARS. THIS DEVICE WAS 2 MONTHS PAST DUE FOR OVERHAUL. THE IMMEDIATE CAUSE OF THE INSPIRATORY AND EXHALATION PRESSURE FAILURES IS TAMPERING AND/OR ATTEMPTED REPAIR. THE PROBABLE CAUSE OF THE A06 ERROR CODE IS THAT THE PEEP WAS SET OVER THE 5 CM H20 SETTING FOR AN EXTENDED PERIOD OF TIME, GREATER THAN THE ALARM DELAY SECOND. THE IMMEDIATE CAUSE OF THE A05 AND A08 ERROR CODES IS TAMPERING AND/OR ATTEMPTED MAINTENANCE. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN INFORMATION REGARDING THE PATIENT. THREE EMAILS WERE SENT AND A VOICE MESSAGE WAS LEFT. THE REQUESTED INFORMATION HAS NOT BEEN PROVIDED BY THE HOSPITAL CONTACT.

    Description of Event or Problem · 1

    THE MANUFACTURER RECEIVED A CALL FROM THE CLINICAL ENGINEERING DEPARTMENT OF THE HOSPITAL ON (B)(6) 2013 ASKING FOR ASSISTANCE OVER THE PHONE IN REPAIRING THEIR MILLENNIUM VENTILATOR. THE VENTILATOR HAD BEEN CONNECTED TO A PATIENT AT THE TIME OF THE INCIDENT. INFORMATION REGARDING THE EVENT COULD NOT BE PROVIDED AS THE RESPIRATORY THERAPIST VENTILATING THE PATIENT AT THE TIME OF THE EVENT WAS OUT OF THE OFFICE. ANOTHER RESPIRATORY THERAPIST WAS AVAILABLE AND STATED THAT SHE WAS UNABLE TO ANSWER QUESTIONS REGARDING THE EVENT, HOWEVER, REPORTED THAT THE PATIENT WAS NOT INJURED. UPON RECEIPT OF THE VENTILATOR IN THE CLINICAL ENGINEERING DEPARTMENT THE DEVICE WAS DISPLAYING AN ERROR CODE OF A06: PROLONGED INSPIRATORY PRESSURE. THE EVENT OCCURRED ON (B)(6) 2013. THE CLINICAL PRESSURE WAS INFORMED THAT THE DEVICE SHOULD BE SENT INTO THE MANUFACTURER FOR REPAIR AND/OR OVERHAUL. ASSISTANCE OVER THE PHONE TO REPAIR THE DEVICE WOULD NOT BE PROVIDED. ON (B)(6) 2013 THE MANUFACTURER RECEIVED A SECOND CALL. THE CLINICAL ENGINEER HAD TRIED TO REPAIR THE VENTILATOR AND IT WAS NOT DISPLAYING ERROR CODES A05: CHECK SENSE LINES AND A08: LOW PEEP/BASELINE PRESSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195332 MILLENNIUM INFANT VENTILATOR MILLENNIUM VENTILATOR CBK SECHRIST INDUSTRIES, INC. 23065-1

    Patients

    Seq Age Sex Outcome Treatment
    1