Model Number 10884450372514 |
Device Problems
Fluid/Blood Leak (1250); Fracture (1260)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 04/23/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The suspect device is not expected to return for evaluation.A follow up will be submitted when the evaluation is complete.
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Event Description
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The account alleges that during the hemodynamic monitoring of a patient, a pressure line tube broke off during use.The circuit was replaced, and the procedure continued.No patient injury to report.
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Manufacturer Narrative
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The suspect device was not returned for evaluation.A photo was provided.The complaint could not be confirmed.The root cause could not be determined.A search of the complaint database was performed and no similar complaints for this lot number were found.The device history record was reviewed, and no exception documents were found.Should the device be returned at a later date, the investigation will be re-opened.
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Search Alerts/Recalls
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