It was reported by the customer that the m540 has lost its configuration and had very poor detection of the ecg signal asystole alarm, although a weak curve was present.The customer reportedly changed the electrodes, leads, and the mode to attempt to remedy the issue with no remedy.The only solution was to switch to 4 leads to obtain a 12 lead ecg, and when the leads were removed the asystole would sound again.The m540 was removed from use.The fse noticed that the malfunctioning m540 had lost its configuration.The repair service tech confirmed that the device was repaired on jan 10, 2024, for mechanical defects including nibp connection and the endcap.The ipml was carried out, and additional testing of the ecg was carried out for 2 days without any ecg interruption.The logs were unavailable for analysis, and therefore the root cause cannot be determined.If the logs are provided for the date and time of the event, the complaint will be reopened to add log findings.Though the root cause cannot be determined, if the ecg reading is poor and has artifacts, there will be no asystole alarm.The device will provide a low-level advisory alarm for the artifact.Additionally, if the m540 loses configuration, alarm limits and settings may be lost.
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