BEUDAMED
    FDA Adverse Event Other Summary report: N

    E360 VENTILATOR

    MDR report key: 1359221 · Received April 7, 2009

    Report

    Report Number
    2023050-2009-00010
    Event Type
    Other
    Date Received
    April 7, 2009
    Date of Event
    March 5, 2009
    Report Date
    March 8, 2009
    Manufacturer
    NEWPORT MEDICAL INSTRUMENTS, INC.
    Product Code
    CBK
    PMA / PMN Number
    K053502
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: ANALYSIS: TURNED THE VENTILATOR ON IN DIAGNOSTIC MODE AND OBSERVED THAT MACHINE 1 PRESSURE SHOWED 149.72 AND THE SEVEN SEGMENTS DISPLAYS WERE ALL OFF. REMOVED THE UNIT TOP COVER AND VISUALLY INSPECTED THE INNER CHAMBER FOR NOTICEABLE DEFECTS; NO PROBLEM WAS FOUND. USED AN OSCILLOSCOPE TO TAKE VOLTAGE MEASUREMENTS OF MACHINE 1 TRANSDUCER XD105 WITHOUT AIR PRESSURE APPLIED TO THE TRANSDUCER. MEASURED 3.6 VOLTS ON XD105 PIN 2 AND 2.68 VOLTS ON PIN 4 WHICH IS INCORRECT. BOTH PINS SHOULD HAVE MEASURED APPROXIMATELY 2.50 VOLTS. LIFTED PINS 2 AND 3 OF OPERATIONAL AMPLIFIER U126 TO ISOLATE XD105. MEASURED 3.50 VOLTS ON XD105 PIN 2 AND 2.53 VOLTS ON PIN 4 WHICH CONFIRMED THAT XD105 WAS DEFECTIVE. NO OTHER DEFECTS WERE FOUND ON THE ANALOG BOARD PCB2104A. CONCLUSION: PROBLEM CONFIRMED. MACHINE 1 TRANSDUCER XD105 LOCATED ON ANALOG BOARD PCB 2104A DOES NOT DELIVER THE CORRECT BIAS VOLTAGE OF 2.50 VOLTS ON PIN 2; IT DELIVERS 3.50 VOLTS. TRANSDUCER XD105 ON PCB2104A WAS FORWARDED TO MANUFACTURER FOR A DETAILED EVALUATION OF THE DIE. THE MANUFACTURER'S INVESTIGATION REVEALED THAT THE SENSOR EXHIBITED INTERMITTENT ELECTRICAL BEHAVIOR. THE INTERMITTENT BEHAVIOR OF THE SENSOR WAS VERY LIKELY TO BE CAUSED BY MICRO FRACTURES ON THE CERAMIC DURING THE PCB ASSEMBLY. THE HARD EPOXY CAN APPLY STRESS ON THE TRANSDUCER LEADS AND CERAMIC. THIS STRESS CAN CAUSE MICRO CRACKS AND AFFECT PERFORMANCE. AS A CORRECTION, THE SPECIFIED SILICON WAS INSTRUCTED TO USE TO SECURE THE TRANSDUCER PINS TO PCB2104A.

    Description of Event or Problem · 1

    REPORTEDLY, THE VENTILATOR STOPPED VENTILATION DURING USE ON A PATIENT WITH DEVICE ALERT (AUDIBLE ALARM) AND ERROR MESSAGE "COMMUNICATION ERROR" ON THE DISPLAY. THE PATIENT'S SATURATION LEVEL WAS TEMPORARILY DROPPED. THE PATIENT WAS MANUALLY VENTILATED FOR 30 MINUTES AND THEN SWITCHED TO ANOTHER VENTILATOR. THE PATIENT'S SATURATION LEVEL WAS BACK TO NORMAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 E360 VENTILATOR CBK NEWPORT MEDICAL INSTRUMENTS, INC. E360 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention