GE Healthcare (NYSE:GE) released an urgent field safety notice to warn of six potential safety issues with its ApexPro telemetry system under certain conditions.
The ApexPro is supposed to provide vital patient information in healthcare settings. But when the ApexPro telemetry transmitter is out of wireless range, its battery has been depleted or a communication failure between the server and transmitter has taken place, a “no telem” condition occurs. This condition, along with “ECG leads fail,” system time changes and system restarts, is related to the potential safety issues, according to the safety notice.
GE Healthcare reported the issues in connection with its Carescape Central Station, the Central Station used in monitoring mode with a Carescape B850/650/450, Dash 3000/4000/5000, Solar 8000M or Clinical Information Center monitor.
The issues include:
- Patients can experience ECG arrhythmias before and after a “no telem” condition and may not re-activate after the condition is resolved. This could result in delayed treatment for the potentially life-threatening ECG arrhythmia event. No injuries have been reported as a result of this issue.
- Patients can experience a “no telem informational” message displayed on the Central Station instead of a high or medium “no telem” alarm, which can lead to delayed treatment for a potentially life-threatening event. No injuries were reported as a result.
- Patients can experience visual and audible SpO2 parameter and technical alarms on the Central Station before a “no telem” condition might not reactivate on the Central Station if the alarm persists. This could result in a delay in treatment for a potentially hypoxic event due to a missed SpO2 alarm. No injuries were reported as a result.
- Patients can experience an audible alarm with visual flashing but without the alarm button and alarm text on display if an SpO2 parameter is set to “high” priority and the “no telem” condition occurs. This can result in a treatment delay for a potentially hypoxic event. No injuries were reported as a result.
- SpO2 parameter data may remain displayed on the Central Station when the SpO2 cable is disconnected from the ApexPro transmitter during backward time adjustment, such as shifting one hour for daylight saving time. This can result in a treatment delay for a potentially hypoxic event. No injuries were reported as a result.
- Alarms set to “medium” or lower priority that are active before an ApexPro server restart can be presented on the Central Station as an “informational” priority after the restart, which can result in a delay in treatment for a potentially hypoxic event. No injuries were reported as a result.
GE Healthcare provided specific instructions for addressing each issue in the notice and said that it will correct all affected products at no cost. The company urged users to discontinue use of previous versions of the ApexPro software and to destroy software media containing previous versions of the software.
The company also confirmed that its field safety notice was offered to the appropriate regulatory agency.