No deathsThe spokesperson emphasizes to the NOS that there have been no reports of deaths as a result of the use of the devices. In the US, the FDA has received 61 incident reports, involving 25 injuries and no deaths. The software problem is now being corrected and according to Philips, the devices can still be used under extra supervision. The manufacturer has initiated the recall itself and reported it to the FDA, which deals with approval in the US. This classifies the risk as “class 1”. This is the “most serious form of recall” and says that the use of devices with this classification could result in “serious injury or death”. The spokesperson could not say whether a report has also been made to regulators in Europe or the Netherlands.
Too little oxygenThe problems are caused by a safety mechanism, the spokesperson said. “For example, a kink in the oxygen tube can cause the pressure in the device to rise too much and then the alarm will go off and the pressure will go down. If that happens to patients with an oxygen deficiency, they don’t get enough oxygen. So the safety mechanism works too well. ” According to the spokesperson, this problem is not common. In June, Philips also had to recall ventilators: 3 to 4 million sleep apnea and ventilators were involved. The company said at the time that no people were known to have died as a result.
Philips recalls ventilators for the second time in a short time
Source link Philips recalls ventilators for the second time in a short time