Model Number 2002-300 |
Device Problem
Filling Problem (1233)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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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 the drainage is unable to reach the 200ml graduation mark on the drain.
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Manufacturer Narrative
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Analysis: the actual drain for the incident was not returned.Two drains related to the incident were returned and evaluated.Once the drains were disinfected a 200ml beaker of blue colored water was poured into the first chamber of the drain through the patient tube line.Both of the drains filled appropriately to the 200ml mark without any fluid spilling into the next collection chamber.A review of the device history records indicates that this lot of chest drains passed all quality requirements.Conclusion: based on the results of the investigation atrium medical corporation cannot conclude that there was any fault of the device.
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Event Description
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N/a.
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Manufacturer Narrative
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Additional information: age or date of birth, sex, and weight.
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Search Alerts/Recalls
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