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 Problems
Inflation Problem (1310); Communication or Transmission Problem (2896); Noise, Audible (3273)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/08/2023 |
Event Type
malfunction
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Manufacturer Narrative
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A supplemental report will be submitted upon completion of our investigation.Due to character restrictions in block e1 telephone number : (b)(6).
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Event Description
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It was reported during a routine check ,the cardiosave intra-aortic balloon pump (iabp) had an "internal communication failure" alarm, a buzzer when it was turned on, and the balloon could not be inflated or deflated.There was no patient involvement reported.
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Search Alerts/Recalls
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