Philips Medical Systems, FSCA 2022-CC-HPM-051, MR Patient Care Portal 5000

During manufacturing inspection of the MR Patient Care Portal 5000, it was discovered that two (2) Portal 5000 units would intermittently not produce audio. There were no messages on the screen indicating speaker failure
while in this state. Additionally, these units would continue to fail to produce audio, even after turning the unit off and on multiple times. Once disconnected from AC power, the unit could regain audio function after being reconnected to AC power and turned on; however, this was not shown to reliably resolve the issue, as the units sometimes remained in the failed state where audio was not functioning. No customer complaints have been received to date regarding this issue.
An investigation determined that the cause of the issue was due to an inadequate circuit design that failed under certain environmental conditions related to input AC voltage, temperature, and humidity.