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 Problems
No Display/Image (1183); Appropriate Term/Code Not Available (3191)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/10/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Testing of actual/suspected device: a getinge field service engineer (fse) evaluated the iabp for the reported "unit has a screen error", and the unit would display error code 14 at power up.The fse observed the system and replaced the compressor and safety disk as per cycle count.He then performed all functional and safety checks to meet factory specifications.Unit passed all functional and safety test per factory specifications.The iabp was then released to the customer and cleared for clinical service.A supplemental report will be submitted upon completion of our investigation.The full event site name is (b)(6) hosp-(b)(6).
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Event Description
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It was reported that prior to use the cardiosave intra-aortic balloon pump (iabp) would display error code 14 at power up.There was no patient involvement, and no adverse event reported.
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Manufacturer Narrative
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The investigation of the compressor, scroll was performed at getinge's national repair center(nrc) per the cardiosave service manual with visual damage observed to the motor power cable connector.The nrc is not able to test the compressor due to the damaged connector.The nrc will retain the compressor in the nrc per procedure.A supplemental report will be submitted upon completion of our investigation.
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Manufacturer Narrative
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Updated fields: b4, g3, g6, g7, h2, h4, h6(investigation type, investigation findings & investigation conclusions), h10, h11.Corrected fields: g1(contact person).
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Event Description
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N/a.
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Search Alerts/Recalls
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