EDWARDS LIFESCIENCES EV1000 PLATFORM; COMPUTER, DIAGNOSTIC, PRE-PROGRAMMED, SINGLE-FUNCTION
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Model Number EV1000A |
Device Problem
Incorrect Measurement (1383)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/03/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The product is expected to be returned for analysis; however, it has not yet been received.Upon the return of the product a supplemental report will be sent with the investigation results.
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Event Description
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As reported, after a while monitoring a patient with this ev1000 system connected to a volumenview kit, the central venous pressure (cvp) values were erratic, moving from 10 mmhg to 30 mmhg and vice versa.The medical staff zeroed the pressure and initially it was correct but after a while the value changed again.No error message was displayed.The patient did not received treatment based on these values.Once the monitor was changed the value was the expected one, under 10 mmhg.There was no allegation of patient injury.The device was available for evaluation.
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Manufacturer Narrative
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Per further information, edwards was informed that the device is not available for evaluation.The reported event 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.The manufacturing records were reviewed and there is no indication of a related nonconformance; all process parameters were met, and inspections passed successfully.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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Search Alerts/Recalls
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