Model Number TABLETOP |
Device Problem
Use of Incorrect Control/Treatment Settings (1126)
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Patient Problem
No Patient Involvement (2645)
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Event Date 05/24/2019 |
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 customer reported following a vitrectomy procedure, the system randomly started to select different settings.The only way to stop the change of settings was to perform a hard system shutdown.After the unit was brought back up, it was now making a loud clicking or clunking noise.The fans were at normal speed the whole time and never ramped up or went super fast or loud.There was no patient involvement.
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Manufacturer Narrative
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The customer called the company representative to assist with troubleshooting.The company representative was able to resolve the reported event remotely with the customer.The 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 is unable to be determined conclusively.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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