DATASCOPE CORP. - MAHWAH CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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Model Number 0998-00-3023-53 |
Device Problem
Premature Discharge of Battery (1057)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/05/2023 |
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 cs300 intra-aortic balloon pump (iabp) batteries didn¿t last.There was no patient involvement reported.
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Event Description
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N/a.
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Manufacturer Narrative
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The getinge service territory manager(stm) evaluated the unit, and replaced the batteries that did not last for the pm.The unit then passed all calibration, functional and safety tests performed.The unit was then returned to the customer and cleared for clinical use.
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Search Alerts/Recalls
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