DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID INT TYPE G PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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Model Number 0998-00-0800-52 |
Device Problems
Failure to Charge (1085); Use of Device Problem (1670)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/24/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Additional information has been requested, and we will report accordingly if it becomes available.Not returned to manufacturer.
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Event Description
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It was reported that during use on a patient, the cardiosave intra-aortic balloon pump (iabp) went into standby mode twice.The iabp was removed and replaced with another.The patient was in stable condition.No patient harm, serious injury or adverse event was reported.
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Manufacturer Narrative
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A getinge field service engineer (fse) evaluated the iabp and was unable to reproduce the reported issue.The safety disk was replaced due to expiration.The fse then performed all functional and safety checks to meet factory specifications.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 during use on a patient, the cardiosave intra-aortic balloon pump (iabp) went into standby mode twice.The iabp was removed and replaced with another.The patient was in stable condition.No patient harm, serious injury or adverse event was reported.
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Event Description
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N/a.
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Manufacturer Narrative
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Updated fields: b4, b6, b7, d9, g3, g6, g7, h2, h6(investigation type), h10, h11.Corrected fields: g1(contact person), h4.
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