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
Detachment of Device or Device Component (2907)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/05/2023 |
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 during preventive maintenance (pm) performed by a getinge service territory manager (stm) , the cardiosave intra-aortic balloon pump (iabp) units doppler is missing.There was no patient involvement.
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Manufacturer Narrative
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The getinge field service engineer(fse) that encountered the issue replaced doppler ultrasonic iabp assembly (0154-01-0596), tether assembly (0997-00-0596), and the clamp block tether (0343-00-0084).The fse completed the pm to factory specifications.The iabp was returned to the customer.
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Event Description
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N/a.
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Search Alerts/Recalls
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