The devicemaker recalled millions of ventilators and sleep apnea machines in 2021 after finding that foam used in the machines could break down and potentially release toxic or carcinogenic materials.
More than 116,000 reports of harm tied to the devices have been shared with the FDA since April 2021, 561 of which involved deaths. Between July and September of 2023, the agency received 111 reports of death related to the machines.
“Philips Respironics investigates all received complaints and allegations of malfunction, serious injury or death,” a spokesperson told Becker’s. “While doing so in line with FDA reporting requirements, the submission of an MDR itself is not evidence that the device caused or contributed to the adverse outcome or event. In addition, in many cases the cause of an event cannot be determined from this reporting system alone.
The devicemaker said it found no conclusive evidence linking these devices to the reported deaths.
The update comes two days after Philips announced it will temporarily stop selling sleep apnea devices in the U.S. under a consent decree agreement with the FDA.
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