Model Number M-4800-01 |
Device Problems
Device Alarm System (1012); Positioning Problem (3009)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 05/19/2016 |
Event Type
malfunction
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Manufacturer Narrative
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The investigation has begun but it has not been completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.Contact office and manufacturing site should reflect: (b)(4).
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Event Description
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It was reported that a map shift of approximately 1-2cm occurred with use of the carto system while at the ablation phase of the procedure.There were no error messages, no patient movement, and no cardioversion had been performed.This is mdr reportable as map shifts without error or warning message could be potentially caused by system malfunction and posed potential risk to patient.
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Manufacturer Narrative
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(b)(4).It was reported that there was a map shift but there were no warnings or error messages displayed on the carto 3 system.Clinical account specialist confirmed that case has already been backed up and removed from the database, therefore data cannot be retrieved for analysis.The provided data is lack with information, based on the available information the root cause of the failure cannot be determined.In addition the customer also declined service since this was a one time occurence and has not happened since complaint was reported.Issue was not duplicated.The history of customer complaints associated with carto 3 system #14569 was reviewed.1 out of 3 additional reported complaints may be related to the reported issue.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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