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Model Number 8300 |
Device Problem
Failure to Calibrate (2440)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/05/2024 |
Event Type
malfunction
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Event Description
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It was reported that the device had failed co2 calibration test.There was no patient involvement.
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Manufacturer Narrative
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Bd technical support troubleshoot with customer over the phone.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 section h6 of this mdr report.Per 803.52(f)(11)(iii) the information provided represents all of the known information at this time.The complainant or reporter was unable or unwilling to provide any further patient, product, or procedural details to the manufacturer.H3 other text : device was not returned to manufacturing facility.
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Search Alerts/Recalls
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