T2024-01 De­lay in de­tect­ing a pa­tien­t’s life­less­ness due to a teleme­try de­vice mal­func­tion on 23 Oc­to­ber 2024

30.01.2026

An elderly patient arrived for an urgent care appointment in South Ostrobothnia, after which they were transferred to a central hospital inpatient ward for further treatment and connected to telemetry monitoring on 23 October 2024. Approximately one hour after tests performed in the morning, the patient was found lifeless in their room and could not be saved despite resuscitation. There was a delay in detecting their lifelessness because the telemetry device had shut down and did not send an alarm to the central monitoring unit.

Monitoring of patients’ condition was mainly based on alarms produced by the telemetry system, but the risks associated with this operating method had not been assessed. Staff training and orientation did not adequately address the need to ensure the safe use of telemetry equipment, and no clear competence requirements had been defined for using the equipment. The responsibilities, roles and job descriptions of the professional user were partly unclear, and device safety competence or an understanding of the importance of telemetry equipment alarms had not been ensured.

The division of responsibilities for maintaining medical devices and monitoring their operating condition was unclear. The service life of telemetry device batteries was not monitored systematically, and some of the batteries had exceeded the recommended maximum service life.

The user interfaces and alarms of the telemetry system were not clear enough to guide users towards safe operation. The instructions for use provided for the equipment were extensive and difficult to apply. There were also no clear quick guide instructions in use.

Information on previous patient safety incidents related to medical devices is fragmented and does not provide a comprehensive national picture. This reduces opportunities to learn from the incidents and systematically develop patient safety.

The investigation resulted in three recommendations, one for the Ministry of Social Affairs and Health and two for the Finnish Medicines Agency Fimea. The Safety Investigation Authority recommends that:

• The Ministry of Social Affairs and Health promote device safety by developing legislation related to medical devices and by directing wellbeing services counties to define the risks and risk management methods related to medical devices.
• The Finnish Medicines Agency Fimea investigate the requirements for the safe use of medical devices and their instructions for use and develop them to better meet the needs of professional users and promote the implementation of safety management related to medical devices.
• The Finnish Medicines Agency Fimea develop the collection of information on patient safety incidents involving medical devices and the processing of patient safety incident reports so that they provide the basis for forming an analysed and up-to-date situational picture and that safety risks can be identified proactively.

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