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Model Number HEM1 |
Device Problem
Incorrect Measurement (1383)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/01/2023 |
Event Type
malfunction
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Manufacturer Narrative
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The product is not expected to be returned for analysis.An investigation will be performed in order to consider any potential factors that may have contributed to this complaint.The serial number was not provided.Therefore, the device history record (dhr) could not be reviewed.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis and any excursions above the control limits are assessed and documented as part of this monthly review.
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Event Description
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As reported, during use in patient with this hemosphere monitor, the cardiac output and cardiac index values were too high, double of what to be expected, therefore afecting the systemic vascular resistance index (svri).As troubleshooting, the backplane, analog pcbe and the oximetry cable were replaced.The customer stopped letting hemosphere do svri calculations, now svri is calculated at the patient monitor.There is no further information available.There was no allegation of patient injury.The device was not available for evaluation.
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Manufacturer Narrative
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Since the affected unit was not returned for evaluation, a product non-conformance or device failure could not be confirmed.Without return of the product, edwards is unable to perform a complete investigation of the reported event.It is not possible to determine what factors may have contributed to it, and therefore no actions could be planned.
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Search Alerts/Recalls
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