Model Number 21-2120-0105-01 |
Device Problem
Device Alarm System (1012)
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Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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Other text: 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 pump keeps getting error codes on the screen.No patient injury reported.
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Manufacturer Narrative
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One device was returned for investigation in good condition.The customer issue was duplicated when the error codes came on screen during functional testing.Root cause was traced to a faulty main board which was replaced to resolve the issue.The product's history records were reviewed and there were no non-conformances nor service-related issues that would have resulted in the reported complaint.
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Search Alerts/Recalls
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