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Hi Guys
we have had three AK98 machines shut down in treatment mode without warning, and generate the following alarm codes on rebooting
0534 049 009 canopen comms error not in error listing
0119 002 007 heartbeat error and 0731 001 000 software task error
this has been reported to the MHRA and Baxter's conclusion was: The complaint reports an event of “heartbeat error”. Based on log file analysis, the system identified a problem, and triggered an alert. The machine worked according to specifications by issuing a dedicated alarm and preventing any potential risk of injury to the patient or the user. The triggered alarm represents a risk control measure. No negative impact on the patient nor the user was reported. No further investigation is deemed necessary at this stage. This Post-Market Surveillance event will be monitored and trended as per applicable risk management plan.
we don't know what or why the failure happened nor how to put it right we cannot make it fail again, power failing in the middle of the night for a nocturnal patient is not very good for them, has anyone else had this issue please let me know.
thanks all
John Barnes
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