Philips investigating patient's death after ventilator failure
A defect in Philips ventilators may have resulted in a person's death. Four other patients may have been harmed following the sudden failure of the devices' alarms, which didn't go off when the devices stopped working. Philips is investigating the matter, a spokesperson confirmed after earlier reports in the Eindhovens Dagblad. The medical technology company previously set aside 70 million euros for this and another recall.
The problem lies with ventilators used in hospitals to support patients who can still breathe independently. It concerns the types V60 and V60Plus. About 105,000 of these ventilators are in use worldwide. Philips said that there is a minimal chance that such a device would stop without an alarm going off. According to the company, it could 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 are the direct result of that technical defect. Philips did not say where these incidents occurred but did say it was not in the Netherlands.
The company contacted the relevant authorities, like the American FDA and the British MHRA, about the possible problem. Philips also contacted all users of the devices. The company is investigating whether and how the problem can be solved.
Hospitals can continue to use the devices but then have to connect an external alarm. Philips also made other recommended precautions mandatory, including measuring the oxygen flow to the patient and the oxygen content in the patient's blood.
Philips also had other problems with ventilators in the past period. Equipment for sleep apnea patients contained insulating foam that could crumble and release toxic substances on contact with certain cleaning agents. Philips set aside 725 million euros to recall millions of those devices. There may be additional compensation.
Reporting by ANP