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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 07/03/2023 |
Event Type
malfunction
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Manufacturer Narrative
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It was further informed that the device was not available for evaluation since it was discarded at hospital.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.The serial number for this device was not supplied; therefore, further review of the related manufacturing records could not be performed.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, when calibrating venous oxygen saturation (svo2), this hemosphere monitor was put on demo mode by mistake.It was not noticed the notification of demo mode on the screen.Therefore, the monitor was calibrated and continued to care for patient in demo mode.The error was noticed when user come back after a break and saw the notification in the screen indicating the monitor was working on demo mode.The patient was not treated according to the values displayed while in demo mode.There was no allegation of patient injury.Patient demographics unable to be obtained.
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Manufacturer Narrative
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The initial report incorrectly stated that the device had been discarded.As per further information obtained no device was returned for evaluation since the device is working correctly.
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Manufacturer Narrative
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Upon further review, updated section h6 (investigations conclusions).Based on the customer reported event description, it could be concluded that the issue was probably caused by the end user.
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Search Alerts/Recalls
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