Model Number INFORNG |
Device Problem
Failure to Deliver (2338)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/22/2022 |
Event Type
malfunction
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Manufacturer Narrative
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The pump was not returned to mmdg for evaluation.A dhr review was completed and no non-conformances were found.Because the device was not returned to mmdg for evaluation, no investigation could be completed.This report will be updated if the device is returned to mmdg.
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Event Description
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The initial reporter stated that the pump was not delivering and that it did not alarm.Mmdg followed up with the initial reporter, who stated that the complaint occurred during testing and that they had no further information about the complaint.(b)(4).
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Manufacturer Narrative
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The pump was returned to mmdg for evaluation.A dhr review was completed and no non-conformances were found.When the pump was returned to mmdg for investigation, it operated as expected.Mmdg could not replicate or confirm the reported complaint.Based on this information, no mdr would have been required.
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Event Description
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The initial reporter stated that the pump was not delivering and that it did not alarm.Mmdg followed up with the initial reporter, who stated that the complaint occurred during testing and that they had no further information about the complaint.(b)(4).
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Search Alerts/Recalls
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