DATASCOPE CORP. - MAHWAH CS100 INTRA-AORTIC BALLOON PUMP, ENGLISH, 220V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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Model Number 0998-00-3013-55 |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/03/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Testing of actual/suspected device (10/213): a getinge field service engineer (fse) was dispatched to evaluate this unit and was able to find electrical test fail #50 error.The fse then checked the motor control board and dried the board with drier.Subsequently, the fse re-checked the unit, and it was able to start normally and worked properly.All parameters and functions were working properly.The fse handed over the machine to the customer in good working condition.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 the cs100 intra-aortic balloon pump (iabp) displayed electrical test fail #50 error.It is unknown the circumstances under which the event occurred.It is also unknown if there was a patient involvement.However, there was no adverse event reported.
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Event Description
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It was reported that prior to use the cs100 intra-aortic balloon pump (iabp) displayed electrical test fail #50 error.There was no patient involvement and no adverse event was reproted.
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Manufacturer Narrative
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All functional and safety tests were passed to meet factory specifications, and the iabp was returned to the customer and cleared for clinical service.
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Event Description
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N/a.
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Manufacturer Narrative
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Updated fields: b4, g3, g6, g7, h2, h4, h6(investigation type, investigation findings & investigation conclusions), h10, h11.Corrected fields: g1(contact person), h6(component codes).
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