DATASCOPE CORP. - MAHWAH CS100 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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Model Number 0998-00-3013-53 |
Device Problems
Electrical /Electronic Property Problem (1198); Failure to Run on Battery (1466)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/11/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Testing of actual/suspected device: a getinge field service engineer (fse) was dispatched to evaluate the iabp and was able to reproduce the reported issue.The fse noted that the iabp unit involved is one only used for training purposes and not on patients.The fse determined that one of the batteries had some corrosion on the contact which was described to be a brownish material.To fix the issue, the fse replaced the batteries then performed all functional and safety checks to meet factory specifications.Unit passed all functional and safety test per factory specifications.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 a training simulation performed by the customer, the cs100 intra-aortic balloon pump (iabp) would not work on battery.There was no patient involved and no adverse event was reported.
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Manufacturer Narrative
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The unit has been cleared for training purposes.
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Manufacturer Narrative
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Updated fields: b4, g3, g6, h2, h10.Corrected fields: h4.
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Search Alerts/Recalls
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