Model Number N/A |
Device Problem
Image Display Error/Artifact (1304)
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Patient Problem
No Information (3190)
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Event Date 12/12/2016 |
Event Type
malfunction
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Manufacturer Narrative
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The product will not be returning to the manufacturer for evaluation; however the investigation was not completed at the time of this report.A follow up medwatch will be submitted once the investigation is complete.
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Event Description
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It was reported that one of the cylinders registered 500ml higher than what the monitor indicated during surgery.Additional information received december 21, 2016 clarified that the monitor was indicating 507 ml; however, it appeared to have 1000ml.
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Manufacturer Narrative
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Information was initially incorrectly submitted on (b)(6) 2016 as 0001526350-2016-00154 stating product was manufactured by dover, oh; however, the device that contributed to the reported event is manufactured by riverside and will be submitted as 0001954182-2017-00002 hereinafter.
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Search Alerts/Recalls
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