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
Failure to Zero (1683)
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Patient Problems
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/04/2022 |
Event Type
malfunction
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Manufacturer Narrative
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A getinge field service engineer (fse) was dispatched to evaluate this unit.The fse observed that the x2 drive pressure transducer was not zeroing out and readings were not within factory specifications.The fse found the leakage in the k7 solenoid.The unit requires a drive manifold assembly for testing purpose to confirm the diagnosis.A supplemental report will be submitted when additional information is provided.The full name of the event site was shortened due to field character limit; the full name is (b)(6).
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Event Description
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It was reported that the cs100 intra-aortic balloon pump (iabp) had an inaccurate balloon waveform on the display.It is unknown under which circumstances the event occurred or if a patient was involved; however there was no adverse event reported.
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Manufacturer Narrative
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Updated data: b4, e2,e3,g2,g3,g6,g7,h2,h10,h11
corrected data: b5,b6,b7,d5,d10,h6(clinical & impact ).
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Event Description
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It was reported that during routine check, the cs100 intra-aortic balloon pump (iabp) had an inaccurate balloon waveform on the display.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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Additional information: event site postal code: (b)(6).A getinge field service engineer (fse) checked and observed that x2 drive pressure transducer is not zeroing.Its showing -370 mm hg reading.After checked the machine thoroughly, found leakage in k7 solenoid.Required drive manifold assembly for testing purpose to confirm the diagnosis.Fes replaced manifold drive assembly (0104-00-0018) to resolve the issue and machine is working fine.
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Search Alerts/Recalls
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