Philips again suffers from safety problems with medical devices. Respirators in hospitals have been found to fail without triggering an alarm. In addition, there is a problem with AEDs (automated external defibrillators). Philips reported the problems to various regulators in recent months, after which the messages came out.
The timing is bad: confidence in the company is already under considerable pressure. Currently, Philips is also embroiled in a massive recall of millions of sleep apnea devices.
The first new issue concerns the risk of electrical interference with ventilators (types V60, V60 Plus and V680) that are used, for example, in intensive care. More than 100,000 of these machines are in use worldwide. The devices can suddenly shut down due to an electrical fault. This has happened hundreds of times so far. In those cases the machine’s alarm went off, but in recent years it has happened six times (as far as Philips is aware) that the alarm did not go off in the event of such a failure. This is a dangerous situation for patients who receive support with their breathing through the device.
A hospital has reported a deceased patient whose alarm had not gone off. Initial investigation by Philips, however, indicated that no such failure had occurred with that machine. Philips is still conducting further investigations. The company is asking hospitals to take extra security measures, such as connecting the machine to the hospital room’s alarm system.
bad stickers
Interestingly enough, this is already the third safety problem with these respirators in the past year. It turned out that outdated glue had been used on three hundred such machines. Doing so could damage an electrical part of it, causing the device to fail. These machines were sold in the US and have been recalled.
Several tens of thousands of these types of ventilators have a software problem that can cause them to shut down when maximum oxygen pressure is reached. Philips technicians are still working on these issues.
The second newly found issue concerns the HeartStart (Type 1) AED machine. About nine hundred thousand of these have been sold worldwide. Such devices deliver shocks when there is a cardiac arrest. The sticker with electrodes that is stuck on the chest appears to be vulnerable. If you remove the foil from the sticker, you can accidentally pull part of the glue along, so that the sticker with electrodes does not stick properly. Philips sends users a set of extra stickers and is working on a new variant of stickers at the same time.
The devices have been on sale since 2010. According to a spokesperson, there were few complaints about the glue in the first years. In 2021, it was complained 84 times, prompting the company to dive in. A report has been received of a patient who died while a patch did not work properly, a Philips spokesperson said. The company is currently investigating whether there is indeed a causal relationship.
Potential health risks
The company spent 74 million euros last quarter to solve new problems with devices, without disclosing what it was about.
Also read: Philips CEO: ‘We are going to work through this setback’
The trouble comes at a bad time: Philips is already replacing five million sleep apnea devices due to potential health risks. This immense operation in more than a hundred countries costs 700 million euros. That is not to mention costs arising from legal claims.
Philips has sold part after part in recent years to focus entirely on medical technology. Due to the setback, the company runs the risk of being seen as less reliable in this area. The company lost 45 percent of its stock market value last year. It is currently worth 24 billion euros.