DATASCOPE CORP. - MAHWAH CS300 INTRA-AORTIC BALLOON PUMP, ITALIAN, 220V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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Model Number 0998-00-3023-67 |
Device Problem
Charging Problem (2892)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/21/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Device not returned: a supplemental report will be submitted upon completion of our investigation.
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Event Description
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It was reported that the cs300 intra-aortic balloon pump (iabp) battery does not hold a charge.It is unknown the circumstances under which the event occurred.It is also unknown if there was patient involvement.However, there was no adverse event reported.
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Manufacturer Narrative
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Testing of actual/suspected device (10): a getinge field service engineer (fse) evaluated the iabp unit, and replaced the batteries to fix the issue.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.A supplemental report will be submitted upon completion of our investigation.
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Event Description
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N/a.
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Manufacturer Narrative
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The batteries that were replaced by getinge fse were due for replacement.A supplemental report will be submitted upon completion of our investigation.
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Event Description
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It was reported that prior to use the cs300 intra-aortic balloon pump (iabp) battery would not hold a charge.There was no patient involvement, thus no adverse event 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, g2, g3, g6, g7, h2, h6(investigation type, investigation findings & investigation conclusions), h10, h11.Corrected fields: d5, g1(contact person), h4.
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