Model Number 8300 |
Device Problems
Failure to Calibrate (2440); Calibration Problem (2890); No Apparent Adverse Event (3189)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/17/2022 |
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 failed calibration/etco2 gas recall 2019.There was no patient involvement.
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Event Description
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It was reported that the device had failed calibration/etco2 gas recall 2019.There was no patient involvement.
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Manufacturer Narrative
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Correction: annex a: a0801.Annex g: g02013.Annex c: c16.Annex d: d03.Additional information: annex a: a25.Annex g: g07001.Annex c: c19.Annex d: d15.
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Search Alerts/Recalls
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