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Model Number 8300 |
Device Problem
Insufficient Information (3190)
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Patient Problem
Insufficient Information (4580)
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Event Date 10/25/2022 |
Event Type
malfunction
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Manufacturer Narrative
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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 while bd employee was on site that the customer has had multiple channel error alerts "over the past few months".Clinical engineering is unable to reproduce alert during testing.There was no information on specific events, patient involvement or patient impact.
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Search Alerts/Recalls
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