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Model Number 203 |
Device Problems
Overfill (2404); Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)
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Patient Problem
Aspiration/Inhalation (1725)
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Event Date 04/26/2017 |
Event Type
malfunction
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Manufacturer Narrative
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The user facility has not returned this device to bunnell, inc.Pending completion of an internal investigation.
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Event Description
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The user reported that while the ventilator was running on a patient the humidifier began to alarm (temp high, circuit level low, circuit fault, continual audible alarm) and "888" was displayed in the humidifier temperature display.The respiratory therapist (rt) noticed a large amount of water in the circuit, which they hadn't noticed previously.The circuit was changed and ventilator was powered down with no resolution.The ventilator was replaced with another life pulse unit.Later that morning, the user facility reported that a significant amount of water had been delivered to the patient when this incident occurred.The patient's fio2 was increased from 21% to 50% following the incident.No other setting needed to be increased.The physician was concerned that the water delivered to the patient had washed out the previously administered surfactant and was considering giving another dose.
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Manufacturer Narrative
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He reported symptom that the humidifier alarmed with a constant audio alarm and all '8's in the temperature display could be verified and was reproduced exactly as reported.This 888 display indicates that the microprocessor controlling the humidifier was reset by the supervisory circuitry.When reset, the humidifier shuts off completely and alarms, disabling the heater, heater wire and water pump.Ventilator function is not affected.The supply voltage, monitored by the microprocessor supervisor, was found to be lower than that specified by bunnell to assure that the circuitry is not susceptible to electrical noise.To correct this issue, the five-volt supply regulator was replaced and all the contacts on the circuit board and in the power distribution cable cleaned.This restored normal operation and provided a degree of electrical noise isolation.Following the aforementioned service, the system was verified to be in calibration and all control and monitoring circuitry were verified to respond correctly to all input variations.The hfv was thoroughly inspected, tested and serviced with no other problems found.System's operation was very stable at a variety of pip and rate settings with no alarms in the hfv ready condition.Hfv 2835 was fully serviced and passed all applicable testing requirements.
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Event Description
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The user reported that while the ventilator was running on a patient the humidifier began to alarm (temp high, circuit level low, circuit fault, continual audible alarm) and "888" was displayed in the humidifier temperature display.The respiratory therapist (rt) noticed a large amount of water in the circuit, which they hadn't noticed previously.The circuit was changed and ventilator was powered down with no resolution.The ventilator was replaced with another life pulse unit.Later that morning, the user facility reported that a significant amount of water had been delivered to the patient when this incident occurred.The patient's fio2 was increased from 21% to 50% following the incident.No other setting needed to be increased.The physician was concerned that the water delivered to the patient had washed out the previously administered surfactant and was considering giving another dose.
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Search Alerts/Recalls
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