Early Alert: Portrait Core Services Software Issue from GE HealthCare

CDRH is issuing this Early Alert to notify the public of a potentially high-risk device issue. The FDA will keep the public informed and update this web page as significant new information becomes available. Affected Product The FDA is aware that GE HealthCare has issued a letter alerting affected customers of updated use instructions for Portrait Mobile Monitoring Solutions devices operating on certain version of Portrait Core Services software.

Affected devices:ProductRef NumberUnique Device Identifier PORTRAIT CORE SERVICES SOFTWARE V1.1570020900195278679284PORTRAIT CORE SERVICES SOFTWARE V1.0.5 569735300195278364838PORTRAIT COMPUTE AND CORE SERVICES V1.2570059200198953056752FRU, PORTRAIT CORE SERVICES SW RELOAD V1.1570022500195278679307What to DoEnsure appropriate alternative monitoring is established for patients before starting a software update. Portrait Mobile Monitoring Solution devices with affected Portrait Core Services software may continue to be used. On July 20, GE HealthCare sent all affected customers a letter recommending the following actions:You may continue to use your Portrait Mobile Monitoring Solution with Portrait Core Services software V1.0.5, V1.1 or V1.2.

Ensure appropriate alternative monitoring is established for patients before a software update is started. Refer to the User Manual addendum provided by GE Healthcare for specific instructions related to alternative monitoring. Place a copy of the addendum with the User Manual for your Portrait Mobile Monitoring Solution with Portrait Core Services SW V1.0.5, V1.1 or V1.2 system in your facility.

Ensure all potential users in your facility are made aware of this issue and the recommended actions. Check this web page for updates. The FDA is currently reviewing information about this potentially high-risk device issue and will keep the public informed as significant new information becomes available.Reason for AlertGE HealthCare stated that during an update of Portrait Core Services software at a facility, some patients who were monitored on Portrait Mobile devices were discharged (removed) from the Portrait monitoring system.

In addition, all alarm settings may be reset to factory defaults following the updates. In this event, the device will not follow the alarm settings previously configured for each patient or care area. This condition can result in a loss of patient monitoring or the intended alarms at the Hub and Central Viewer.

As of July 29, GE HealthCare has not reported any serious injuries or deaths associated with this issue.Device UseThe Portrait Mobile Monitoring Solution is intended to acquire, store, calculate, display and export patient monitoring data as well as provide real time alarming for monitoring adult and pediatric patients.Contact InformationCustomers in the U.S. with adverse reactions, quality problems, or questions about this issue should contact GE HealthCare at (800) 437-1171.Unique Device Identifier (UDI)The unique device identifier (UDI) helps identify individual medical devices sold in the United States from distribution to use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified more quickly, and as a result, problems potentially resolved more quickly.How do I recognize a UDI on a label?

AccessGUDID database - Identify Your Medical Device Benefits of a UDI SystemHow do I report a problem?Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.