DATASCOPE CORP. - MAHWAH CS100 INTRA-AORTIC BALLOON PUMP, ITALIAN, 220V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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Model Number 0998-00-3013-67 |
Device Problems
Failure to Power Up (1476); Failure to Pump (1502)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/02/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Device not accessible for testing: additional information is being requested with regard to the repair and status of the iabp.A supplemental report will be submitted if this information is provided to us.
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Event Description
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It was reported that the cs100 intra-aortic balloon pump failed to power up.It is unknown if there was patient involvement.There was no adverse event reported.
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Manufacturer Narrative
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Testing of actual/suspected device (10/3233): a getinge field service engineer (fse) was dispatched to evaluate the iabp.To fix the issue, the fse replaced the helium outlet fitting because it was observed to be broken.All functional and safety checks were performed to meet factory specifications.Unit passed all calibration, 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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It was reported that the cs100 intra-aortic balloon pump does not start.It was later clarified that the iabp unit was unable to be started as it would not fill with helium.It is unknown under which circumstances this event occurred; however there was no patient involvement, and no adverse event was reported.
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Manufacturer Narrative
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Updated fields: b4, g4, g7, g8, h2, h4, h6 (type of investigation, investigation findings, investigation conclusions), h10, h11.Corrected field: g1 (contact person ¿ mfg site).
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Event Description
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N/a.
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Search Alerts/Recalls
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