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Model Number 21-7302-24 |
Device Problem
Product Quality Problem (1506)
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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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A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56, when additional reportable information becomes available.
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Event Description
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It was reported, the disposable caused the device to randomly beeped continuously.No adverse patient effects were reported by the customer.
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Manufacturer Narrative
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No product was returned.We are unable to confirm the reported complaint.If the product is returned, smiths medical will reopen this complaint for further investigation.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.No product was returned; therefore, no visual and functional tests were performed, the reported complaint could not be confirmed, and the root cause could not be determined.
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Manufacturer Narrative
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No serial number was provided, due to this, no device history review was completed.
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Search Alerts/Recalls
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