Model Number AVOX4000 |
Device Problem
High Test Results (2457)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 12/05/2017 |
Event Type
malfunction
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Manufacturer Narrative
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This mdr references accriva diagnostics' complaint number (b)(4) for avoximeter 4000 co-oximeter serial number (b)(4).A child case capturing the cuvette and lot number of the disposable device tested with this instrument is 7053171-31711 and is referenced by accriva diagnostics' complaint number (b)(4).Actual device not evaluated.Process evaluation was performed.Dhr reviewed showed no ncrs, capas, instrument repairs or other anomalies related to this complaint.Results: no results available since no evaluation performed.Conclusion: device not returned.Accriva has requested all data required for form fda 3500a.
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Event Description
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Healthcare professional reported an unexpectedly high %cohb result with an avoximeter 4000 co-oximeter in a continuously ventilated nursing home patient.Blood gases and co-oximetry tests were being conducted every 12 hours.Test results were as expected except for one unexpectedly high %cohb result (5.2%) that was clinically significant and above the patient's 48-hour baseline %cohb of 2.1%.The patient received an unspecified treatment and subsequent blood gases and co-oximeter results returned to baseline.An internal investigation did not find any evidence that the patient was exposed to carbon monoxide.No medical complications or other events were reported.
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Manufacturer Narrative
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Correction: patient weight was not specified - please delete the (b)(6) value previously entered.
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Event Description
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Follow-up #2.
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Manufacturer Narrative
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Mdr 2250033-2018-00004 follow-up #1 references acriva diagnostics' complaint number (b)(4) for avoximeter 4000 co-oximeter serial number (b)(4), which was evaluated in response to the customer's complaint.(b)(4).Accriva diagnostics has requested all data required for form fda 3500-a.No previously unobtainable information reported in the initial mdr is available.
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Event Description
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Follow-up #1.
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Search Alerts/Recalls
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