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 03/04/2024 |
Event Type
malfunction
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Manufacturer Narrative
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A supplemental report will be submitted upon completion of our investigation.(b)(6) 2024 dv addl iu info : customer found, during use.
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Event Description
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It was reported that during customer use the cs300 intra-aortic balloon pump (iabp) had a failing battery.It was only lasting 30 minutes.There was no patient involvement.
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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 (fse) evaluated the iabp and was able to confirm the reported issue.To fix the issue, the fse replaced the batteries.Then, the fse completed full calibration, functional testing, and safety check to factory specification.The unit passed all tests performed and was returned to the customer in good working conditions.
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Event Description
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It was reported that during use the cs300 intra-aortic balloon pump (iabp) had a failing battery.It was only lasting 30 minutes.There was no patient harm reported.
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Search Alerts/Recalls
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