The FDA says that these popular devices were linked to 168 deaths

The products of a company are associated with important victims.


Cars we drive to work in the morning untilcooking devices We use to prepare dinner when we get home, we count on countless different devices to get the day. And while we are aware ofSome risks So that we can meet, most of us expect a certain level of security for large companies and the products they produce. In a new alert, drugs and American food administration (FDA) warn the Americans that a popular group of devices generally used at night may not be sure after all - in fact, these products were linked to 168 deaths . Read the rest to find out which dangerous devices you may want to avoid.

Read this then:If you have these drugs on CVS, Rite Aid or Walgreens, do not take them, warns the FDA.

The FDA warns consumers of dangerous medical devices.

doctor has bad news for male patient at hospital
istock

The FDA publishes "Safety communications"Each year, alert the public to the current problems with medical devices and what the agency recommends protecting consumers. The agency has published a certain number of these communications in 2022. From January to March, the FDAsent several alerts Undering consumers to stop using certain hairdressing home tests, largely due to a high risk of false results. More recently, the agency has warned parents, caregivers and health care providers not to be usedBaby's neck floats Due to the risk of death or injury.

"The FDA monitors adverse event reports and other problemswith medical devices And alerts health professionals and the public if necessary to ensure appropriate use of devices and patient health and safety, "said the agency.

Now, an FDA security communication alerts the public on a popular type of device that has been linked to more than 150 deaths.

An alert has been updated to warn the Americans for the link of a company at 168 deaths.

Elderly patients in hospital bed
istock

On August 16, the FDAUpdating a safety communication He published last year with regard to several respiration respironics philips breathing devices in order to "provide the latest information" to the public. In June 2021, the agency alerted people who use Philips fans, pressure machines from the posititive respiratory tract in Bilevel (BIPAP) and continuous machine pressure machines (CPAP) that theThe company had recalled Several versions of these devices due to potential health risks. These products are all used to help breathe, Bipap and CPAP machines being mainly used by those who have sleep apnea.

"This update provides additional recall information for people who use repaired and replaced devices," the FDA said in its new alert. Last year, the agency said there had been no death report due to problems related to these devices. Now, that is no longer the case.AE0FCC31AE342FD3A1346EBB1F342FCB

According to the FDA, manufacturers like Philips are required to submit reports of medical devices (MDR) when "information suggests that their device may have caused or contributed to a death or serious injuries, or misguided and this device Or a similar device that they manufacture would be likely to cause or contribute to a death or serious injuries if the malfunction was to reproduce. "In its update in August 2022, the FDA said it had now received More than 69,000 mdr which includes 168 reports of deaths associated with recalled devices.

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Deaths have been linked to a major problem with these devices.

Sleep Apnea Oxygen Mask Equipment And CPAP Machine
istock

The FDA said that the 168 death reports are linked to the polyurethane foam rupture based on polyester (PE-PUR) or a suspected foam rupture. According to the agency, Philips uses this foam in its devices to "reduce sound and vibrations in these devices and other medical equipment", but in the recalled devices, the foam has the potential to decompose.

"If this happens, pieces of black foam or certain chemicals that are not visible could be inspired or swallowed by the person using the device," said the FDA. "The PE-Pur foam problem can result from exposure to hot and humid conditions and can be exacerbated by the use of ozone cleaners or other cleaning methods not recommended by the manufacturer."

The FDA said that these devices can cause serious injuries even if the death does not occur.

older woman sitting down and having breathing trouble
Whisper

Exposure to pieces of foam or chemicals while PE-Pur decomposes "could potentially cause serious injuries and require medical intervention to prevent permanent injuries," warned the FDA. The agency said that a "wide range of injuries" had been reported in the 69,000 mdr that it had received so far ", in particular cancer, pneumonia, asthma, other respiratory problems, Infection, headache, cough, dyspnea (difficulty breathing), dizziness, nodules and chest pain. "

According to the fda, ​​the potential risks from inhaling or swallowing pieces of the black foam include irritation to the skin, eyes, nose, and respiratory tract, inflammatory response, headache, asthma, and toxic or cancer-causing effects to the organs like the The kidneys and the liver. Likewise, the potential risks of inhalation of chemicals released in the air tubes of the foam device include headache, dizziness, irritation in the eyes, nose, respiratory tract and skin , a hypersensitivity reaction, nausea or vomiting and toxic effects or cancer cancer.


Categories: Health
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