Catalog Number 8065750833 |
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 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 a system is freezing up.The timing of the event and patient impact are unknown.Additional information has been requested but none has been received.
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Manufacturer Narrative
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(b)(4).
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Event Description
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New information received from the customer stated the event occurred during a cataract surgery.The system would freeze when the pole would move up and down.The surgery was completed.There was no patient harm.
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Manufacturer Narrative
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The system was examined and the reported event was replicated.The host was replaced to resolve the issue.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 january 26, 2012.Based on qa assessment, the product met specifications at the time of release.The cause of the reported event can be attributed to the non-conforming host module.However, how that host module became non-conforming remains inconclusive.(b)(4).
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Search Alerts/Recalls
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