Catalog Number 8419350 |
Device Problem
Occlusion Within Device (1423)
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Patient Problems
Cyanosis (1798); Low Oxygen Saturation (2477)
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Event Date 04/02/2018 |
Event Type
Injury
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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 during use the patient¿s sputum occluded the leak valve of the device.As a result the patient¿s spo2 decreased and the patient suffered cyanosis.After replacement of the circuit the patient recovered.
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Event Description
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Please refer to the initial-report.
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Manufacturer Narrative
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The affected device was checked by dräger service on-site and no malfunction could be found.The log file was sent to the manufacturer for detailed investigation.Based on the log entries the device generated the visual and audible alarm ¿leakage valve blocked¿ three times around the reported time of the event.There are no log entries indicating a device malfunction.It can be concluded that the device reacted as specified to an occluded leak valve by generating the corresponding alarm.No device malfunction could be detected.
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Search Alerts/Recalls
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