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Model Number IPN000320 |
Device Problem
Communication or Transmission Problem (2896)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/25/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Qn#: (b)(4).
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Event Description
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It was reported that the pump is not capturing and pumping on every beat.As a result, the staff swapped to a second console with all the original signals/cables and had no issues.There was no report of patient complications, serious injury, or death.
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Event Description
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It was reported that the pump is not capturing and pumping on every beat.As a result, the staff swapped to a second console with all the original signals/cables and had no issues.There was no report of patient complications, serious injury, or death.
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Manufacturer Narrative
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Qn# (b)(4).No iabp part or recorder strip was returned to teleflex chelmsford for investigation.The reported complaint of the pump missing beats is not able to be confirmed.The root cause of the complaint is undetermined.A device history record (dhr) review was conducted for the lot number with no relevant findings.The device passed all manufacturing specifications prior to release.Teleflex assessed the risk for the reported complaint.There are no new or revised risk.This will be monitored for any developing trends.
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Search Alerts/Recalls
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