Catalog Number 8065753057 |
Device Problems
Power Problem (3010); Unexpected Shutdown (4019)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Event Description
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A customer reported that an ophthalmic operating console presented problems with alternating current (ac) unplugging from wall and console shuts down.The procedure details and patient impact were not provided.Additional information has been requested but none received till date.
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Manufacturer Narrative
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Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).
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Manufacturer Narrative
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The company representative confirmed and replicated the reported event.The nonconforming multifunctioning in/out (mfio) printed circuit board (pcb) was replaced to resolve the issue.The system was tested and found to meet product specifications.A non-conformance-based review of the batch/lot/serial number was performed and did not reveal any potential contributing factors to the reported complaint.A manufacturing device history record (dhr) review was performed prior to product release to ensure that the product was manufactured in compliance with the device master record.Based on the assessment, the product met release criteria.A review for complaints reported against this lot/batch/serial number was performed.No similar complaints were reported for the product lot/batch/serial under investigation.The root cause of the reported event is attributed to the nonconforming mfio pcb.Manufacturer will continue to monitor data for evidence of adverse trending and take further action, as appropriate.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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