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Catalog Number FG540000J |
Device Problem
Fire (1245)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/26/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The hardware 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.Initial reporter phone: (b)(6).If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).
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Event Description
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It was reported that when the loaner carto® 3 system was returned to the j&j (b)(4) repair center, the loaner team confirmed smoke emitted from the device after it was turned on.Fire was not reported.There was no report of adverse event to any person.
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Manufacturer Narrative
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It was reported that when the loaner carto® 3 system was returned to the j&j sukagawa repair center, the loaner team confirmed smoke emitted from the device after it was turned on.Fire was not reported.There was no report of adverse event to any person.Device evaluation details: the biosense field service engineer (fse) confirmed that the workstation (ws) was repaired by local dell engineer.The cause of the the smoke was the input/output (i/o) board.The i/o board was replaced.In addition, the mother board was replaced due to another problem found.The system is ready for use.The faulty i/o was discarded by dell engineer, therefore, further investigation by the manufacturer could not be performed.The history of customer complaints reported during the last year associated with carto 3 system #50015 was reviewed.No similar complaints were found.The manufacturing record evaluation was performed on carto 3 system, and no internal actions related to the reported complaint condition were identified.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# pc-(b)(4).
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Manufacturer Narrative
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On 8-jun-2022, the manufactured date of 21-oct-2010 was provided, therefore, field h4.Device manufacture date been populated.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).
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Search Alerts/Recalls
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