As reported, with this demo hemosphere for edwards employee's, the power cable was split and sparks could be observed, with no smoke or fire.Edwards employee was not aware of liquid ingress to the cable.The issue did not cause any damage.Replacing the cable the problem was solved.There was no patient involved.Follow-up has started for device return.
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Update: d4 (expiration date), g3 (date received by manufacturer), h3 (device evaluated by manufacturer), h4 (manufacturer date), h6 (investigation findings, investigation conclusions) the damaged cable involved in this event was not available for evaluation since it was discarded.Therefore, 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.Based of further engineering investigation the operator's manual was reviewed and it has multiple warnings regarding using the power cord with installed power cord entry cover.Failure to do so may result in fluid ingress.Also, not to use detachable power cords other than the power cord provided.The manual also warns: do not use any damaged or non-compatible platform accessories, components or cables.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.H3 other text : the cable was discarded.
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