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Device Problem
Audible Prompt/Feedback Problem (4020)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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No lot number was provided; therefore, device history record review could not be completed.The reported issue could not be confirmed as no product sample was received for evaluation.If the product is returned, the manufacturer will reopen this complaint for further investigation.Udi and catalog and reported to fda are unknown.No product information has been provided to date.
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Event Description
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It was reported that one of new remodulin cadd cassette, prior to change over tonight, alarmed steady beeping.No patient injury was reported.
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Search Alerts/Recalls
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