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Model Number 8300 |
Device Problem
Application Program Freezes, Becomes Nonfunctional (4031)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/11/2023 |
Event Type
malfunction
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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 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.Device was not returned to manufacturing facility.
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Event Description
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It was reported that the 8300 had error code 9-100-1318.There was no patient involvement.
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Search Alerts/Recalls
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