The issue involves the Portrait Mobile Monitoring Solution and could lead to patients being removed from the system or alarm settings resetting during updates.

The Food and Drug Administration (FDA) issued an early alert to notify the public of a potentially high-risk software issue involving GE HealthCare Portrait Core Services. The issue affects the Portrait Mobile Monitoring Solution, a system designed to acquire, store, calculate, display, and export patient monitoring data for adult and pediatric patients.

According to GE HealthCare, some patients monitored on Portrait Mobile devices were discharged from the monitoring system during a software update at a facility. Additionally, all alarm settings may reset to factory defaults following an update, meaning the device would not follow previously configured settings for specific patients or care areas. This condition could result in a loss of patient monitoring or intended alarms at the hub and central viewer.

Affected Software Versions

The alert applies to several versions of the software and related components, including:

  • Portrait Core Services Software V1.1
  • Portrait Core Services Software V1.0.5
  • Portrait Compute and Core Services V1.2
  • FRU, Portrait Core Services SW Reload V1.1

GE HealthCare sent a letter to affected customers on July 20 recommending specific actions to mitigate risks. While the affected devices may continue to be used, the company and the FDA emphasize that healthcare providers must ensure appropriate alternative monitoring is established for patients before starting any software update.

The FDA and GE HealthCare recommend that facilities take the following steps:

  • Refer to the user manual addendum provided by GE HealthCare for instructions on alternative monitoring.
  • Place a copy of the addendum with the system user manual.
  • Ensure all potential users in the facility are made aware of the issue and the recommended actions.

As of July 29, GE HealthCare has not reported any serious injuries or deaths associated with this software issue, says the FDA alert. The agency is currently reviewing information regarding the issue and plans to provide updates as new information becomes available.

Customers in the US with questions or quality problems regarding the issue are encouraged to contact GE HealthCare. Adverse reactions can also be reported to the FDA MedWatch safety information and adverse event reporting program.

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