Model Number 550AVHCT |
Device Problem
Incorrect, Inadequate or Imprecise Result or Readings (1535)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Manufacturer Narrative
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Per the manufacturer's technical support specialist, it was stated that there were inaccurate values and that the hematocrit saturation (h/sat) probe values displayed dashes.
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Event Description
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It was reported that the blood parameter monitor (bpm) displayed inaccurate values.No other details regarding the nature of this event were provided.
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Manufacturer Narrative
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The reported complaint could not be confirmed.The service repair technician (srt) was unable to verify the reported complaint.The arterial blood parameter monitor (bpm) and venous bpm passed intensity testing.Erasable electronically programmable read only memory (eeprom) did not list any critical error codes.The unit operated to the manufacturer's specifications.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.
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Manufacturer Narrative
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During laboratory analysis, the product surveillance technician was unable to verify the reported complaint.The monitor was powered up with no error codes displaying.Calibration and verification function was also successful.In-vivo adjustments were made to fine tune the on-screen values and all adjustments were made successfully.The monitor functioned as intended throughout the evaluation.
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Event Description
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Additional information was received that the hematocrit (hct) and oxygen saturation (svo2) were the values that were inaccurate.The reported issue occurred during set-up for a cardiopulmonary bypass (cpb) procedure.The surgical procedure was completed successfully.As mitigation, values were retrieved from a blood gas analyzer.There was no delay, no blood loss, nor adverse consequences to the patient.
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Search Alerts/Recalls
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