Model Number IPN001112 |
Device Problem
Gas/Air Leak (2946)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 05/03/2021 |
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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There was no patient involvement.It was reported that the intra-aortic balloon pump (iabp) have been using "a lot of helium".The user stated that the tanks seem to be empty when the iabp weren't even in use.
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Manufacturer Narrative
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Qn# (b)(4).The product was not returned for investigation.The reported complaint of helium tank running out quickly was confirmed by the field service agent.According to the attached fsr, the pcs assembly was replaced.The root cause of the complaint is undetermined.If the product is returned at a later date, a full investigation of the sample will be completed.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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Event Description
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There was no patient involvement.It was reported that the intra-aortic balloon pump (iabp) have been using "a lot of helium".The user stated that the tanks seem to be empty when the iabp weren't even in use.
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Search Alerts/Recalls
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