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.

Farbrikant: Philips Medical Systems
Product: MR Patient Care Portal 5000
Datum FSN: 15-09-2022

Waarschuwing van de fabrikant

Dit bericht is een waarschuwing van de fabrikant. Na het op de markt brengen van een medisch hulpmiddel is de fabrikant verplicht het hulpmiddel te volgen en waar nodig te verbeteren. Wanneer sprake is van een risico voor de gebruiker moet de fabrikant actie ondernemen. De fabrikant informeert gebruikers en de inspectie over deze actie met een waarschuwing (Field Safety Notice). Zie ook waarschuwingen medische hulpmiddelen. Dit hoort bij het toezicht op medische technologie.