DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID W/ E/F PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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Model Number 0998-00-0800-55 |
Device Problem
Failure to Power Up (1476)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/13/2023 |
Event Type
malfunction
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Manufacturer Narrative
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A supplemental report will be submitted upon completion of our investigation.
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Event Description
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It was reported that before use, the cardiosave intra-aortic balloon pump (iabp) ignition test failed.There was no patient involvement reported.
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Manufacturer Narrative
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A getinge field service engineer (fse) had evaluated the unit and than the fse had reinstalled the software , calibrated the touchscreen, by adjusting the coil cable connections, by calibrating the transducers the performance of the tests were being passed according to the manual and verification of correct operation of the equipment.
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Manufacturer Narrative
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Updated fields: b4, g3, g6, h2, h10, h11 corrected fields: h6 (remove 3331 from type of investigation).
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Event Description
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N/a.
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Search Alerts/Recalls
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