DATASCOPE CORP. - MAHWAH CS300 INTRA-AORTIC BALLOON PUMP, FRENCH, 220V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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Model Number 0998-00-3023-64 |
Device Problem
Failure to Sense (1559)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/11/2021 |
Event Type
malfunction
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Manufacturer Narrative
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A getinge field service engineer (fse) was dispatched to evaluate the unit and after checking the pump, the logs and having a conversation with the users about the issue, it appears that it was all a use problem.According to what the users claimed, they were surprised to see the pump stopped to perform the balloon fo calibration.Their first reaction began by touching "many keys", they finished with no augmentation (unit "not pumping") and the low diastolic pressure alarm.The users finally swapped to "manual" mode and the patient could be transferred with no injury.When the investigation to the user was completed, the fse complete a preventive maintenance (pm) on the machine.Unit passed all functional and safety test per factory specifications.The iabp was released to the customer and cleared for clinical service.A supplemental report will be submitted when additional information is provided to us.
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Event Description
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It was reported that during use on a patient, the cs300 intra-aortic balloon pump (iabp) had a fiber optic problems and the user had to move it to make it work.The patient was transferred to another hospital with no injury linked to the unit.The service engineer will check this iabp during the normal pm.
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Manufacturer Narrative
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Updated fields; b4, b6, b7, d4, d9, g3, g6, g7, h2, h6, h10, h11.Corrected fields: d1, g1.
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Event Description
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N/a.
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