DATASCOPE CORP. - MAHWAH CARDIOSAVEHYBRID INT TYPE E/F PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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Model Number 0998-00-0800-55 |
Device Problem
Charging Problem (2892)
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Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/01/2021 |
Event Type
malfunction
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Manufacturer Narrative
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A getinge field service engineer (fse) was dispatched to evaluate this unit.The fse confirmed the iabp was not seated in the cart properly which prevented the battery from charging.Once the iabp was reseated, it began charging properly.The iabp functions as intended.(b)(6).
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Event Description
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It was reported that during preventive maintenance (pm) performed by a getinge field service engineer (fse), the cardiosave intra-aortic balloon pump (iabp) batteries would not charge, even when connected to network.There was no patient involvement, and no adverse event reported.
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Manufacturer Narrative
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Unit is with the customer.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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Event Description
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N/a.
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Manufacturer Narrative
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The unit has been cleared for clinical use.The full address of the event site in block e1 was shortened due to field character limit; the full address is (b)(6).The telephone# for initial reporter is (b)(6).
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Manufacturer Narrative
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Updated fields; b4, g3, g6, g7, h2, h6, h10, h11.Corrected fields: g1, h4, h6 (health effect - clinical code, investigation conclusions).
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Event Description
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N/a.
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Search Alerts/Recalls
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