No product was returned for evaluation.Without the return of the product, it is not possible to determine if damages or defects existed on the product, nor could a root cause or potential contributing factors be identified.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.Hospital information is confidential therefore, device availability could not be determined.
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As reported, as per customer feedback about flotrac system, co values provided not always match up in patients in low cardiac output.No further information was available since the hospital information was confidential.There was no allegation of patient injury reported.The device was not available for evaluation.
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