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Model Number 21-7302-24 |
Device Problems
Device Alarm System (1012); 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 that during the use of the product, a "no message" alarm a "no disposable, pump won't run" alarm went off.No patient injury.
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Manufacturer Narrative
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Other text: no product was returned.The reported complaint could not be confirmed.If the product is returned this complaint will be reopened for further investigation.A valid lot number was not provided; therefore, a history record review could not be conducted.B3: unknown; no information has been provided to date.
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Search Alerts/Recalls
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