SIAF investigates telemetry unit malfunction: delay in detecting patient’s unresponsiveness

The Safety In­ves­ti­ga­tion Au­thor­ity, Fin­land (SIAF) has de­cided to launch a safety in­ves­ti­ga­tion into a mal­func­tion of a teleme­try unit that led to a de­lay de­tect­ing a pa­tien­t’s un­re­spon­sive­ness in South Os­tro­both­nia on 23 Oc­to­ber 2024. The pa­tient died de­spite re­sus­ci­ta­tion at­tempts (CPR).

The patient was connected to the telemetry unit in the hospital ward. S/he was found lifeless. At the same time, a telemetry device malfunction was detected.

The aim of a social and healthcare safety investigation is to improve public safety and prevent further adverse events (accidents) and incidents from occurring. Questions of legal liability or compensation are not addressed in safety investigations.

“Medical device safety is a very important aspect of customer and patient safety. The review of practices related to medical devices and ensuring safety are at the core of the investigation that has now been launched. The purpose of medical devices may be, for example, to monitor a patient’s health status. If a device malfunctions, the consequences can be very serious. The malfunction is a fact. Our task among others is now to find out which contributing factors caused the malfunction,” says Hanna Tiirinki.

The Safety Investigation Authority will continue its investigation by collecting background information and documents, conducting interviews and examining the device itself. Safety investigations always investigate the causes and consequences of adverse events, incidents and accidents. The launched investigation will focus on the management of safe use of medical devices, the assessment of risk factors associated with their use and the practices for operating and maintaining the devices.
The Safety Investigation Authority received a notification of the incident from the Finnish Medicines Agency (Fimea).

“It was Fimea’s wish that OTKES investigate the incident in order to determine the root causes of the incident. Information is needed to promote the safe use of medical devices. We have extensive investigative powers to investigate an adverse event of this nature. Although we start from a single event, we also look at a more general phenomenon. The important thing is that the event is investigated,” adds Hanna Tiirinki, Investigator in Charge.

The duration of a safety investigation is approximately 9-12 months. The Safety Investigation Authority will provide more information on the investigation once the investigation progresses.