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Catalog Number IAP-0500 |
Device Problems
Gas/Air Leak (2946); Incomplete or Inadequate Connection (4037)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 09/25/2019 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported that the intra-aortic balloon pump (iabp) helium tank gauge fluctuated back and forth.With random amounts of psi 10- 100+, also 1 unable to refill alarm.The pumping resumed after alarm, fluctuating psi did not affect the therapy.Patient successfully weaned from iab as planned.The patient has remained stable off the pump.There was no report of delay in therapy.There was no report of patient complications, serious injury or death.
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Manufacturer Narrative
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(b)(4).Teleflex received the device for investigation.The report complaint of helium reading fluctuated and unable to refill alarm is confirmed based on the customer picture/video provided, however, the returned helium regulator assembly passed visual and functional test specifications during the complaint investigation.The root cause of the complaint is undetermined.Teleflex assessed the risk for the reported complaint.There are no new or revised risks.This will be monitored for any developing trends.No further action required at this time.
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Event Description
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It was reported that the intra-aortic balloon pump (iabp) helium tank gauge fluctuated back and forth.With random amounts of psi 10- 100+, also 1 unable to refill alarm.The pumping resumed after alarm, fluctuating psi did not affect the therapy.Patient successfully weaned from iab as planned.The patient has remained stable off the pump.There was no report of delay in therapy.There was no report of patient complications, serious injury or death.
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Search Alerts/Recalls
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