Model Number TABLETOP-JAPAN |
Device Problem
Failure to Shut Off (2939)
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Patient Problem
No Patient Involvement (2645)
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Event Date 05/27/2019 |
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.The manufacturer internal reference number is: (b)(4).
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Event Description
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A surgeon reported the system froze while shutting down following surgical procedures.There was no patient involvement.
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Manufacturer Narrative
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The company service representative examined the system and replicated the reported event.The dual in-line memory module (dimm) was replaced to resolve the issue.Unrelated to the reported event, the company service representative found system message (sm) [the lamp has exceeded its rated life: lamp needs to be replaced.Please contact field service] in the event log.The xenon lamp was replaced to resolve the issue.The system was then tested and met all product specifications.The system manufacturing device history record (dhr) was reviewed.Based on qa assessment, the product met specifications at the time of release.The root cause of the reported event can be attributed to nonconforming dual in-line memory module (dimm).The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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