Model Number 3600-100 |
Device Problems
Suction Problem (2170); Noise, Audible (3273)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 11/02/2018 |
Event Type
malfunction
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Manufacturer Narrative
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We are in the process of performing the investigation and will submit the follow-up report once the evaluation is completed.
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Event Description
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Report received stated that a chest drain was connected to the chest tube and the drain was making a humming sound and did not appear to have proper suction.All of the connections were checked to see if there was a leak and none were found.A new chest drain was opened and attached and the issue was resolved.
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Event Description
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N/a.
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Manufacturer Narrative
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The drain was received and inspected.There was a small amount of dried blood in the first collection chamber.The drain was set up per the instructions for use (ifu).The water seal chamber was still filled to the proper 2cm fill line per the instructions for use.The drain was then placed under vacuum.The vacuum setting of the drain regulator was not moved and was at the shipped setting of -20 cmh2o.The wall vacuum pressure was set to -109mmhg and the suction tube was placed on the suction port of the drain.No unusual noises were noticed.The regulator of the drain was cycled down to -10cmh2o and all the way to the maximum setting of -40cmh2o.Still no humming sound was heard.The vacuum pressure was then increased to -140mmhg.When this high negative pressure was applied there was still no humming noise coming from the chest drain.The chest drain in all instances was functioning properly.The device history records associated with this lot of drains were reviewed and found to be complete and have met all the finished good specifications.Clinical evaluation: the oasis single chest drain system is indicated for the evacuation of air and/or fluid from the chest cavity or mediastinum and to help re-establish lung expansion and restore breathing dynamics.The instructions for use (ifu) states the suction source should be set to -80 mmhg or higher for chest drain regulator settings of -20 cmh2) or greater.
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Search Alerts/Recalls
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