It was reported that the following issue was observed on the device: "screen says 'calibrate', passes calibration, screen still says 'calibrate'." additional notes provided by the facility¿s clinical engineering support services include: "i recalibrated the unit and ran it through all of its pm tests.Sometimes these units can have an issue if the calibration date and the pm date don't match." reported problem cause description: "calibration adjustment." there was no reported patient involvement.Although additional information and product return have been previously requested, the customer provided a general statement that ¿no further information will be provided, including patient demographics and no products will be returned.¿.
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A device history record review is performed on each device reported in a mdr reportable event along with other methods of investigation as coded in section h6 of this mdr report.Per 803.52(f)(11)(iii) the information provided represents all of the known information at this time.The complainant or reporter was unable or unwilling to provide any further patient, product, or procedural details to the manufacturer.H3 other text : no product will be returned.
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