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Model Number M-4800-01 |
Device Problems
Leak/Splash (1354); Over-Sensing (1438); Device Displays Incorrect Message (2591)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 06/04/2015 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported that during an afib - atrial fibrillation procedure, a current leakage error was displayed on the carto3 system, and the signal interference (noise) was observed on all ecg (bs + ic) channels on both carto 3 system and recording system.There was no evidence, whether the physician had at least one ecg signal available to monitor patient's heart rhythm.This type of issue is assessed as reportable event.The case was continued by passing carto 3 and the customer had all lead signals after switching to ge system body surface leads.The procedure was completed without any patient consequence.
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Manufacturer Narrative
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Evaluation summary: (b)(4).It was reported that during an afib - atrial fibrillation procedure, a current leakage error was displayed on the carto3 system, and the signal interference (noise) was observed on all ecg (bs + ic) channels on both carto 3 system and recording system.There was no evidence, whether the physician had at least one ecg signal available to monitor patient¿s heart rhythm.This type of issue is assessed as reportable event.The case was continued by passing carto 3 and the customer had all lead signals after switching to ge system body surface leads.The procedure was completed without any patient consequence.Biosense field service engineers were able to reproduce current leakage error upon initialization of the system.Field service engineers swapped ecg cards into different slots.Field service engineers booted up the system and the current leakage error did not appear then.Fse performed acceptance testing to confirm system was functioning normally.All tests passed and the system is ready for use.Dhr review was performed by the manufacturer and no anomalies were noted in manufacturing or servicing of this equipment.
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Search Alerts/Recalls
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