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 01/24/2023 |
Event Type
malfunction
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Manufacturer Narrative
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The device was returned to mmdg for investigation.A dhr review was completed and no non-conformances were found.The device was returned to mmdg, but at the time of this report, the investigation was not completed.This report will be updated when the investigation information is available.
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Event Description
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The initial reporter stated that the pump was not alarming no food as expected.They stated that it failed to alarm.Mmdg followed up with the initial reporter, who stated that the complaint had occurred during testing and had not had any affect on a patient.Complaint- (b)(4).
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Manufacturer Narrative
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The device was returned to mmdg for investigation.A dhr review was completed and no non-conformances were found.The device was returned to mmdg, but at the time of this report, the investigation was not completed.This report will be updated when the investigation information is available.
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Event Description
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The initial reporter stated that the pump was not alarming no food as expected.They stated that it failed to alarm.Mmdg followed up with the initial reporter, who stated that the complaint had occurred during testing and had not had any affect on a patient.Complaint- (b)(4).
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Manufacturer Narrative
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The device was returned to mmdg for investigation.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 was not alarming no food as expected.They stated that it failed to alarm.Mmdg followed up with the initial reporter, who stated that the complaint had occurred during testing and had not had any affect on a patient.(b)(4).
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Search Alerts/Recalls
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