Model Number 8100 |
Device Problems
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 03/30/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Bd technical support troubleshoot with customer over the phone.A follow up report will be submitted with investigation results should the device be repaired or the device/logs be received for evaluation.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.Device was not returned to manufacturing facility.
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Event Description
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It was reported that the 8100 fails rate calibration test.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 section h6 of this mdr report.
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Event Description
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It was reported that the 8100 fails rate calibration test.There was no patient involvement.
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Search Alerts/Recalls
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