DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID, TYPE B PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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Model Number 0998-00-0800-53 |
Device Problems
Pumping Stopped (1503); Communication or Transmission Problem (2896)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/23/2023 |
Event Type
malfunction
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Event Description
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It was reported during patient transport, the cardiosave intra-aortic balloon pump (iabp) unit alarmed with communications error and stopped pumping.End user reset power to unit and pumping resumed.Unit alarmed again and stopped pumping again.Customer then had to removed batteries to reset unit power and stop alarm.Pumping was resumed and patient was removed from unit.There was no patient harm or injury reported.
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Manufacturer Narrative
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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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A getinge field service engineer evaluated the unit and found issues with multiple unit calibration values.Replaced front end board and drive manifold to ensure proper calibration reading processing, and manifold solenoid valve operation.Performed complete calibration, functional testing and safety checks.Unit passed all functional and safety tests per factory specifications, returned unit to customer.
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Search Alerts/Recalls
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