GE HealthCare has issued updated use instructions for all Portrait Mobile Monitoring Solutions operating on certain versions of Portrait Core Services software, according to an FDA early alert.
The 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.
Reason for Alert
The FDA reports 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, the FDA says. 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, according to the FDA.
As of July 29, GE HealthCare has not reported any serious injuries or deaths associated with this issue.
Affected Devices
| Product | Ref Number | Unique Device Identifier |
|---|---|---|
| PORTRAIT CORE SERVICES SOFTWARE V1.1 | 5700209 | 00195278679284 |
| PORTRAIT CORE SERVICES SOFTWARE V1.0.5 | 5697353 | 00195278364838 |
| PORTRAIT COMPUTE AND CORE SERVICES V1.2 | 5700592 | 00198953056752 |
| FRU, PORTRAIT CORE SERVICES SW RELOAD V1.1 | 5700225 | 00195278679307 |
FDA Recommendations
Ensure 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.
More info is available on the FDA website.
