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Model Number SWAN GANZ UNKNOWN |
Device Problem
Incorrect Measurement (1383)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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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 lot 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, during use in patient, in this swan ganz catheter, the continuous cardiac index (cci) displayed is sometimes not reliable.There was no allegation of patient injury.
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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.Therefore, a root cause could not be determined.Nevertheless, as part of the catheter manufacturing process, the units go through an electrical inspection and instructions for use provides information to verify electrical continuity prior to the catheter insertion.
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Search Alerts/Recalls
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