ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER CONSTELLATION VISION SYSTEM; UNIT, PHACOFRAGMENTATION
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Model Number TABLETOP |
Device Problem
Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 01/18/2017 |
Event Type
malfunction
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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.(b)(4).
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Event Description
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A customer reported that during mid-vitrectomy procedure, the system locked.There was no response from the touchscreen and the system fan went into over-drive.The customer forced a firmware reload by pressing and holding standby switch.However, upon restart, inlet pressure stats was showing 0 psi.A second reboot of the system cleared the issue and the case was completed.There was no patient harm.
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Manufacturer Narrative
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The system was examined but was unable to identify anything associated with the reported event(s).However, the fan kit and the power module were both replaced.The system was tested and found to meet product specifications.A review of the customer¿s complaint history for the last 24 months did not show any previous complaints of this kind against the system.The system was manufactured on september 11, 2014.Based on qa assessment, the product met specifications at the time of release.The system was found to meet specifications.Therefore, the root cause of the reported event cannot be determined conclusively.(b)(4).
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Search Alerts/Recalls
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