DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID, TYPE I PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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Model Number 0998-00-0800-45 |
Device Problem
No Display/Image (1183)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/29/2024 |
Event Type
malfunction
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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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It was reported that during use on a patient, the cardiosave intra-aortic balloon pump (iabp) had no blood pressure waveform display.It was necessary to replace it with another one.There was no patient harm reported.
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Manufacturer Narrative
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Corrected data: b5.Updated data: b4, e1 (initial reporter), e2, e3, g3, g6, h2, h10.
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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) had no blood pressure waveform display.It was necessary to replace it with another one.It was later reported that the device was not connected to the patient when the event occurred.There was no patient harm reported.
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Search Alerts/Recalls
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