Model Number 8300 |
Device Problems
Calibration Problem (2890); Insufficient Information (3190)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/06/2022 |
Event Type
malfunction
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Event Description
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It was reported that the device had a failed leak down test and failed preventive maintenance.There was no patient involvement.
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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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Manufacturer Narrative
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Correction: annex b: b21.Annex c: c21.Annex d: d16.Additional information: annex a: a26.Annex b: b17.Annex c: c20.Annex d: d15.Annex g: g07002.
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Event Description
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It was reported that the device had failed leak down test and failed preventive maintenance.There was no patient involvement.
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Search Alerts/Recalls
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