Duizenden new reports of problems with apneu devices Philips: toezichthouder VS reports 82 doden | Nieuws

In November and December, Philips reported 8,000 new reports of problems with patients who might have had problems with defective new appliances. In 82 van der Gevallen what he said from a solid state, reports the Amerikaanse toezichthouder voor medical apparatuses FDA.

The problems with the slaapapneu-apparaten draaien om het isolatieschuim in the machines. Dat kon affrokkeln of chemical substances afgeven na contact met bepaalde schoonmaakmiddelen, met mogelijke Schade voor de gezondheid als gevolg. In total, Philips had 5.5 million devices due to defects.

Philips called for a separate update that more than 90 percent of the 99,000 reports from April 2021 reported incidents that had serious consequences. Then there is a notification of an incident near the use of the conscious apparatus not directly because the association is required to be the one that writes the medical-technological concern in the Netherlands.

In total zijn 346 overlijdens reported the possible te maken hebben gehad met the ondeugdelijke apparatus. Philips shows all the notifications of the separate zones, but that there are too many because they raise the risk that the sterfgevallen are connected with the technical problems.

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