ST. JUDE MEDICAL ENSITE X EP SYSTEM DISPLAY WORKSTATION; COMPUTER, DIAGNOSTIC, PROGRAMMABLE
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Model Number ENSITE-DWS-01 |
Device Problem
Output Problem (3005)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/20/2023 |
Event Type
malfunction
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Event Description
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During the pulmonary vein isolation procedure, it was reported that the system was slow and unable to map smoothly and there were several messages that appeared during system bootup.The computer was rebooted and switched to voxel mode, but the issue did not resolve.The procedure was abandoned with no adverse patient consequences, and subsequently completed later.The dws was replaced and the relevant software and modules were installed.
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Manufacturer Narrative
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Additional information: g3, h2, h3.Based on the information provided to abbott and the images submitted, the occurrence of the reported event can be confirmed.The image appear to show that there was a power on sequence symptom related to machine check errors (mce) related to the central processing unit (cpu or processor).The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.No non-conformances associated with the reported event were identified.
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Manufacturer Narrative
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Additional information: d9, g2, h2, h3, h6.One ensite x display workstation was received.Based on the returned images, the investigation, and information provided to abbott, the reported event was able to be confirmed, however the root cause was unable to be identified as the returned symptom was not reproduced.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.No non-conformances associated with the reported event were identified.
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Search Alerts/Recalls
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