The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) announced it has recalled GE’s ApexPro telemetry server after multiple reported events of monitoring equipment not providing visual or audible alarms for ECG arrythmias, lead failures or SpO2 monitoring.
The potential safety issues are:
- 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.
The company has alerted users to discontinue use of previous versions of the ApexPro software and to destroy software media containing previous versions of the software.