BEUDAMED
    FDA Adverse Event Other Summary report: N

    NEWPORT MEDICAL

    MDR report key: 1208803 · Received October 21, 2008

    Report

    Report Number
    MW5008698
    Event Type
    Other
    Date Received
    October 21, 2008
    Date of Event
    October 21, 2008
    Report Date
    October 21, 2008
    Manufacturer
    NEWPORT MEDICAL INSTRUMENTS, INC.
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SUBJECT: THREE DEFECTIVE VENTS IN A ROW. HEALTHCARE THERAPIST JUST LEFT AFTER TRYING TO GET THIRD NEWPORT HT-50-H VENTILATORS - IN A ROW TO WORK. WHEN THEY COULDN'T MAKE THIS VENTILATOR TO WORK PROPERLY, THE THERAPIST CALLED YOUR TECH SUPPORT. THEY ASKED THE THERAPIST A NUMBER OF QUESTIONS AND THEN SAID TO SEND THE VENTILATOR IN FOR REPAIR. I SENT YOU AN EMAIL -SEE BELOW- IN 2008 ASKING YOU ABOUT THE EXCESSIVE FAILURE RATE OF YOUR HT-50-H VENTILATORS. I'M NOT CERTAIN IF THESE VENTILATORS ARE NEW OR REPAIRED VENTS. IF THEY WERE REPAIRED, EITHER YOU AND/OR APRIA HAVE A SERIOUS PROBLEM THAT NEEDS ADDRESSING. I CONSIDER THREE DEFECTIVE VENTILATORS IN A ROW TO BE A SERIOUS PROBLEM, SO I AM SENDING THIS EMAIL TO MEDICAL CENTER. LETTER SENT 10/01/2008. MY ISSUES WITH THE HT-50-H VENTILATORS STARTED WITH THE FIRST HT-50-H VENT HEALTHCARE. IN BROUGHT IN 2004. A NUMBER OF MONTHS AGO, MY PULMONOLOGIST DECIDED I NEEDED 24-HOUR HUMIDIFICATION. HEALTHCARE BROUGHT TWO NEW HT-50-H VENTS WITH HUMIDIFICATION UNITS. THE FIRST VENT OUT OF THE BOX FAILED TO CALIBRATE THE EXHALATION VALVE. THE SECOND ONE USING THE SAME CIRCUIT USED ON THE FIRST VENT COMPLETED THE EXHALATION VALVE CALIBRATION. THE THIRD VENT THEY BROUGHT WORKED. I DON'T REMEMBER WHY IT WAS NECESSARY AT THE END OF AUGUST TO REPLACE ONE OF THESE VENTILATORS, BUT IT WAS. THE REPLACEMENT VENTILATOR WORK WELL FOR 3 HOURS AND THEN STARTED HAVING A CONTINUOUS "HUMIDIFICATION ERROR". IN 2008 HEALTHCARE REPLACED VENT. THIS VENTILATOR INTERMITTENTLY DOESN'T CLOSE THE EXHALATION VALVE COMPLETELY. ARE THE TECHNICIANS WHO REPAIR THESE VENTILATORS FOR HEALTHCARE CERTIFIED BY CO? IS CO ABLE TO ACCESS THE REPAIR RECORDS OF THE VENTS LISTED ABOVE? I KNOW MY DESCRIPTIONS OF THESE PROBLEMS VAGUE AND NON-TECHNICAL, BUT IS IT POSSIBLE THAT THESE CONDITIONS MAY BE COVERED BY REPAIR SERVICE BULLETINS? IT IS VERY DISTURBING TO HAVE A BACKUP VENTILATOR THAT IS NOT RELIABLE. CURRENTLY, ONLY THE VENTILATOR I AM USING IS WORKING BUT IF IT BEGINS TO HAVE A PROBLEM, I CAN'T RELY ON THE REPLACEMENT ONE. I WANT TO ADD THAT MY COMPLAINT IS NOT ABOUT THE SERVICE PROVIDED BY THE LOCAL OFFICE. MY COMPLAINT IS ABOUT THE REPAIRS IS MAKING TO THE NEWPORT HT-50-H VENTILATORS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEWPORT MEDICAL VENTILATOR CBK NEWPORT MEDICAL INSTRUMENTS, INC. HT-50-H
    2 NEWPORT MEDICAL VENTILATOR CBK NEWPORT MEDICAL INSTRUMENTS, INC. HT-50-H
    3 NEWPORT MEDICAL VENTILATOR CBK NEWPORT MEDICAL INSTRUMENTS, INC. HT-50-H

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other