One bci® capnocheck® sleep capnograph/oximeter was returned for investigation.Visual inspection of the device revealed that the tamper sticker had been removed and the battery was disconnected from the mainboard inside the device.Additionally, it was noted that the rechargeable battery was not a designated battery that smiths medical installs.During functional testing, the device was powered on with a test power supply and it was noted that the power/charge green indicator light did not power on.The device was opened and examined and it was observed that the heatsink was warmer than usual; however, no smoke was found escaping from the device.Further examination of the device found that the output voltage at the charging section of the main board was elevated which resulted in excessive voltage being delivered to the heatsink.The excess voltage at the heatsink caused the heatsink to overheat.Additionally, the switch output voltage at the regulator was too low to turn the device on with ac power and the battery was not charging.The observed missing tamper sticker and the non-smiths medical designated battery indicated that the device was tampered with by the user; therefore, investigation was unable to determine the root cause of the failed mainboard component.After device repair and recalibration, the device was found to pass all delivery, accuracy and functional tests.
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