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
Connection Problem (2900)
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Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/08/2022 |
Event Type
malfunction
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Manufacturer Narrative
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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 use on a patient, cs300 intra-aortic balloon pump (iabp) unit's ecg didn't have a waveform.The customer changed the console, cables, etc.Three times with no success.It was suggested that the problem was likely a conduction issue based on the troubleshooting attempts.It was recommended that the customer move two of the ecg patches, adding water soluble doppler gel prior to placing them.The customer was also instructed to move two of the electrodes to the patients back and move the other two more anterior.This gave a waveform immediately but a screenshot of the pump's screen showed the ecg still had some artifacts.
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Event Description
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It was reported that during use on a patient, cs300 intra-aortic balloon pump (iabp) unit's ecg didn't have a waveform.The customer changed the console, cables, etc.Three times with no success.It was suggested that the problem was likely a conduction issue based on the troubleshooting attempts.It was recommended that the customer move two of the ecg patches, adding water soluble doppler gel prior to placing them.The customer was also instructed to move two of the electrodes to the patients back and move the other two more anterior.This gave a waveform immediately but a screenshot of the pump's screen showed the ecg still had some artifacts.There was no patient harm or injury reported.
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Manufacturer Narrative
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A getinge field service engineer (fse) attended the issue on call and reported that customer didn't have a waveform.Customer changed the console, cables, etc.Three times with no success.It was suggested that the problem was likely a conduction issue based on the troubleshooting attempts.It was recommended that the customer move two of the ecg patches, adding water soluble doppler gel prior to placing them.The customer was also instructed to move two of the electrodes to the patients back and move the other two more anterior.This gave a waveform immediately but a screenshot of the pump's screen showed the ecg still had some artifacts.Fse suggested to continue the work with the electrodes until they are able to get a good waveform.Unit cleared for clinical service is unknown.H3 other text : customer handled the issue.
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Search Alerts/Recalls
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