Catalog Number 8603800 |
Device Problems
Decrease in Pressure (1490); Inaccurate Delivery (2339); Gas/Air Leak (2946); Therapeutic or Diagnostic Output Failure (3023)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/21/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The investigation has just started; results will be provided in a follow-up report.
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Event Description
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It was reported that he device posted alarms during use on a patient and that automatic ventilation did not work.The patient was transferred to another ventilator.No patient consequences have reportedly occurred.
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Manufacturer Narrative
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The event was reported with one month delay to dräger and, the device remained in use.It took another 4 weeks to secure the log file and thus, the section in which alarms and user interactions are recorded was already overwritten for the period in question.The error log section does not contain any entry that would point to a malfunction of the device.There are however numerous entries which indicate partly massive leaks in the patient circuit outside the device.During the dispatch to secure the log file the dräger service engineer has performed a self-test with the device which was passed without deviations.Due to unavailable log file data for the time of event, a reliable conclusion in terms of root cause for the event can't be drawn.Reflecting the facts - absence of malfunction during on-site check, no recorded technical error codes and the aspect that the device remained in use after the event - it is seen likely that there is no issue with the device which would require repair or correction.The workstation is equipped with pressure and flow monitoring which will trigger corresponding alarms if the effects of leakages in the pneumatic circuit exceed the compensation capabilities of the device.All types of alarms, potential root causes and dedicated remedies are listed in the ifu.
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Event Description
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It was reported that he device posted alarms during use on a patient and that automatic ventilation did not work.The patient was transferred to another ventilator.No patient consequences have reportedly occurred.
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Manufacturer Narrative
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Due to a technical issue with our internal emdr system we submitted for the form fda 3500a an incorrect value for the field h3.- not returned to manufacturer.
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Event Description
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It was reported that he device posted alarms during use on a patient and that automatic ventilation did not work.The patient was transferred to another ventilator.No patient consequences have reportedly occurred.
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Search Alerts/Recalls
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