Waakhond vs warns of malips Philips-heart monitor for home

This article was last updated on January 24, 2025

Canada: Oye! Times readers Get FREE $30 to spend on Amazon, Walmart…
USA: Oye! Times readers Get FREE $30 to spend on Amazon, Walmart…

Waakhond vs warns of malips Philips-heart monitor for home

A Philips device that allows heart patients to monitor their heart rhythm at home has not worked properly. The FDA, the American medical watchdog, has linked 2 deaths and 109 cases of health damage to the failure of the cabinets. In the latter cases, the supervisor does not say what exactly happened.

According to Philips it is about US patients and this model is not used in the Netherlands. These are Mobile Cardiac Outpatient Telemetry (McOT), a kind of plaster with a monitor. With this sticker, heart patients can keep their heart rhythm at home. Medical specialists keep an eye on the heart films remotely. The device is from Braemar Manufacturing, a subsidiary of Philips.

The reports were made between July 2022 and July 2024. In some cases, heart films made at home were not properly forwarded to the cardiologist. As a result, certain important reports about abnormal heart rhythms were not received properly.

The FDA takes the failure of the cabinets very seriously and is talking about a recall. According to Philips, this does not mean that patients have to return the cabinets. What matters is that the software on the devices is updated.

It is up to the medical specialists to take action. Through a database, the doctors can see if there are patients who have received the device in question. Depending on the health of the patient, a doctor must estimate whether it is necessary to contact this person.

In a response to the NOS, Philips said that it had acted “quickly and proactively”. After the deaths, the healthcare technology company itself reported the incident to the American watchdog. Philips says the device is currently working normally again.

Apnea

It is not the first time that the FDA has intervened in a Philips medical device. In 2021, the company had to recall millions of units of apnea devices. In some cases the foam in the equipment came loose. Thousands of reports followed from patients who associated the release of the foam with respiratory complaints. Deaths were also linked to the failure of the devices.

In this case too, it was a subsidiary of Philips, the American company Respironics. Philips has always said that no conclusive evidence has been provided for a connection between the complaints and the use of the apnea devices. The costs for the device itself were reimbursed, but there is still a lawsuit on health damage.