Model Number 00884450092712 |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/06/2022 |
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 use, the device was found to be leaking.No additional patient consequence to report.
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Manufacturer Narrative
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The suspect device was not returned for investigation.The complaint could not be confirmed.The root cause could not be determined.The device history record was reviewed, and no exception documents were found.A search of the complaint database was performed and no similar complaints for this lot number were identified.Should the device be returned later, the investigation will be reopened.
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Search Alerts/Recalls
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