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 Problem
Component Incompatible (1108)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/29/2023 |
Event Type
malfunction
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Event Description
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It was reported that during preventive maintenance (pm) performed by a getinge service territory manager (stm) , the cardiosave intra-aortic balloon pump (iabp) unit failed fill manifold test.There was no patient involvement.
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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 during planned maintenance device failed fill manifold test.Replaced helium reservior (997-00-0565), retested device.Device passed with no issues.Verified unit calibrated and passes all functional and safety tests per factory specifications, returned to customer and cleared for clinical use.The defective components were received for further investigation.The failure analysis and testing department was unable to replicate the failure experienced by the customer.Retaining the helium reservoir assembly in the failure analysis and testing department per procedure 0002-07-d008 rev ap.The root cause selection for this investigation will be ¿not confirmed' due to the failure analysis and testing department was unable to replicate the failure.The non-conformances with the returned components were not confirmed.However, the root cause or the most probable root cause is not confirmed.
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