DATASCOPE CORP. CS100 INTRA-AORTIC BALLOON PUMP, REFURBISHED, ENGLISH,NON-UTS,INTL; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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Model Number 0998-UC-3013-55 |
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 12/12/2023 |
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 general use it was found that the cs100 intra-aortic balloon pump (iabp) battery back up time is low.There was no patient involvement reported.
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Manufacturer Narrative
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A getinge field service engineer (fse) was dispatched to evaluate the unit.The fse reported that there was a low battery backup.The (fse) reported that after replacing the unit's batteries the unit was handed back to customer in good working condition.
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Event Description
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N/a.
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Manufacturer Narrative
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**udi related data quality updates only** providing updated device identification information in alignment with gudid (d1, d2, d3, d4, g4, h4, h5).
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Event Description
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N/a.
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Search Alerts/Recalls
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