The problem arises with the ventilators used in hospitals to support patients who can still breathe on their own. It concerns the types V60 and V60 Plus. Of these, 105,000 are in use worldwide. Philips says there is a very small chance that the device will stop without sounding an alarm. That would happen once every million times the device is used.
Recently, Philips received 383 reports of unexpected failures of the devices. In 377 cases, the device failed, but the alarm went off, so doctors and nurses could intervene quickly. In six cases, no alarm went off. Philips is now investigating whether the death of one patient and the injury of four others is the direct result of that drop-out. Where those cases occurred has not been disclosed, but at least not in the Netherlands.
The company itself contacted the relevant authorities such as the American FDA and the British MHRA about the possible problem. Philips will also contact all users of the devices. The company is also investigating whether and how the problems can be solved.
Hospitals can continue to use the devices, but then have to connect an external alarm that is often built into rooms in intensive care. Other precautions that were previously recommended have also been made mandatory by Philips, such as measuring the oxygen flow to the patient and the oxygen content in the patient’s blood.
Recently, Philips had more problems with ventilators. Equipment for sleep apnea patients contained insulating foam that could crumble and release toxic substances on contact with certain cleaning agents. Philips has now set aside 725 million euros for the recall for millions of those devices. There may be additional compensation.