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Model Number 204 |
Device Problems
Display or Visual Feedback Problem (1184); Insufficient Heating (1287)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/09/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The device was returned to bunnell, and an investigation completed in (b)(6) 2020.The reported symptom of not reading the temperature and a humidifier check circuit alarm could not be verified and was not reproduced as reported.Operation was very stable in the hfv ready condition with no alarms of any type generated.The cartridge heater plate and circuit heater wire were verified to be operating correctly and the humidifier monitored temperatures were stable and accurate.No problems of any type were found with the humidifier processor cca.There is nothing wrong with this device.The systems calibration was optimized for peak performance and all control and monitoring circuitry was verified to be responding correctly to all input variations.Hfv a1307 was fully serviced and passed all applicable testing requirements.At the time of the investigation it was determined that this event was not reportable.As such, no manufacturer report was filed at that time.However, user facility report (b)(4) was received on (b)(6) 2021.Although this event is not reportable, this report is being submitted in response to this user faciltiy report within 30 days of its receipt.
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Event Description
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As reported on user facility report (b)(4): "bunnell jet alarming, (check circuit temp.) no temperature on panel noted.Circuit cold to touch.Troubleshooting done and then, jet switche out.Jet ventilator was pulled from patient bedside and replaced with additional vent".As reported to bunnell at the time of the event: "no temp reading, alarm check circuit temp." no patient injury.
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Search Alerts/Recalls
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