Model Number 8300 |
Device Problems
Device Alarm System (1012); Insufficient Information (3190)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/14/2022 |
Event Type
malfunction
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Manufacturer Narrative
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A device history record review is performed on each device reported in a mdr reportable event along with other methods of investigation as coded in this mdr report.Per 803.52(f)(11)(iii) the information provided was obtained from servicing activities performed on the device.There were no additional details obtainable or provided at the time of service.
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Event Description
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It was reported that the device had channel error and oridian issue.There was no patient involvement.
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Manufacturer Narrative
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Correction: annex b: b21.Annex c: c21.Annex d: d16.Additional information: annex a: a26.Annex g: g07002.Annex b: b17.Annex c: c20.Annex d: d15.
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Event Description
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It was reported that the device had channel error and oridian issue.There was no patient involvement.
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Search Alerts/Recalls
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