Analysis confirmed that the atrial output connector was loose (nut was not fastened).The battery voltage for both was 1.42 volts.An incoming test was performed on the automated test system and the device failed on the uut serial number reading.The nut of the ventricular output connector was not fastened.The device was cleaned and inspected, nuts of both connectors were tightened, and the device was tested and calibrated on the automated test system and passed.All found defective parts were replaced and all other identified issues were resolved.The device then passed all final functional tests.If information is provided in the future, a supplemental report will be issued.
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