Catalog Number 689610/JPB |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 03/03/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The suspect device is 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, the pressure monitoring set was found to be leaking fluid.No patient injury to report.
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Manufacturer Narrative
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The suspect device has been returned for evaluation.The product was examined visually.The complaint is confirmed.The root cause is attributed to a crack on the component, it is likely that significant force was applied to the device during use.A search of the complaint database found one similar complaint for this lot number from the same customer.The device history record was reviewed and no exception documents were found.
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Search Alerts/Recalls
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