Model Number INFKIT2 |
Device Problem
Protective Measures Problem (3015)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/26/2022 |
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 pump was not returned to mmdg, 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 did not alarm.They didn't state what alarm was expected.The initial reporter stated that this occurred during testing and had not affected a patient.They also stated they had no further information about the complaint.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 device 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 did not alarm.They didn't state what alarm was expected.The initial reporter stated that this occurred during testing and had not affected a patient.They also stated they had no further information about the complaint.[complaint- (b)(4)].
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Search Alerts/Recalls
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