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Model Number 8300 |
Device Problem
Computer Software Problem (1112)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/26/2022 |
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 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.No product will be returned.
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Event Description
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It was reported that the device alarmed when attached to pcu.Although asked, the customer was unable to specify the type of alarm and did not provide the details of the issue.There was no patient involvement.
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Search Alerts/Recalls
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