Model Number TABLETOP |
Device Problem
Inappropriate or Unexpected Reset (2959)
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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.The manufacturer internal reference number is: (b)(4).
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Event Description
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A customer reported the unit is re-booting by itself.Additional information has been requested but not received.
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Manufacturer Narrative
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The company service representative examined the system but did not indicate replicating the reported event.The company service representative checked all the connections to the laser on their system.The company service representative added electrical tape to the motherboard to better insulate the board from the ground.The system was then tested and met all product specifications.The system manufacturing device history record (dhr) was reviewed.Based on assessment, the product met specifications at the time of release.The root cause cannot be determined conclusively.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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