ST. JUDE MEDICAL ENSITE PRECISION MODULE, SENSOR ENABLED (US); COMPUTER, DIAGNOSTIC, PROGRAMMABLE
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Model Number H702470 |
Device Problem
Sparking (2595)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/07/2021 |
Event Type
malfunction
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Event Description
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During device preparation, when powered on, sparking was noted.The system was replaced and the procedure was completed with no adverse patient consequences.
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Manufacturer Narrative
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One ensite¿ precision¿ link sensor was received into the lab for analysis. inspection of the power inlet connector at the rear of the chassis confirmed the field reported issue as one of the four pins is discolored or blackened.The psu (power supply unit) in use at the time of the reported event was not returned for evaluation.Functional testing was performed to ensure communication and accurate positions were actively tracked within the magnetic acquisition area.All catheter ports and patient reference sensor ports were tested.No error messages or communication drops were displayed during the evaluation period.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The review determined that no non-conformances were identified that are related to the reported event.Based on the information provided to abbott and the investigation performed, the root cause of the field reported issue was isolated to an electrical arc at the rear power inlet connector from an undetermined event.
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