Model Number N/A |
Device Problem
Gas/Air Leak (2946)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Manufacturer Narrative
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A getinge service territory manager (stm) was dispatched to evaluate the iabp.The stm noticed that the cart itself was not holding helium.The stm performed cart test and found the regulator connector was covered on a green substance.The stm additionally indicated that upon trying to remove the regulator it would not budge.Subsequently, the stm requested a loaner unit for the customer and the iabp will be shipped to (b)(6) for repair.
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Event Description
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It was reported that the cardiosave intra-aortic balloon pump (iabp) has a helium leak.It is unknown under which circumstances this event occurred.There was no harm or injury to the patient and no adverse event was reported.
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Event Description
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It was reported that the cardiosave intra-aortic balloon pump (iabp) has a helium leak.It is unknown the circumstances under which the event occurred.It is also unknown if there was a patient involvement.However, there was no adverse event reported.
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Manufacturer Narrative
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Another getinge service territory manager (stm) assisted the first stm that had evaluated the iabp and started repairs.It was identified that there were two leaks.The cart was leaking helium & the rescue was also leaking helium.The hose set was replaced to fix the cart leak, and the fill manifold to fix the leaking from the rescue.Then, all functional and safety checks to meet factory specifications were performed.Unit passed all functional and safety test per factory specifications.The iabp was then released to the customer and cleared for clinical service.
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Event Description
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It was reported that the cardiosave intra-aortic balloon pump (iabp) has a helium leak.It is unknown the circumstances under which the event occurred.It is also unknown if there was a patient involvement.However, there was no adverse event reported.
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Search Alerts/Recalls
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