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[av_heading heading=’Defective CPAP and respiratory devices’ tag=’h1′ style=’blockquote modern-quote’ subheading_active=’subheading_below’ show_icon=” icon=’ue800′ font=’entypo-fontello’ size=” av-desktop-font-size-title=” av-medium-font-size-title=” av-small-font-size-title=” av-mini-font-size-title=” subheading_size=” av-desktop-font-size=” av-medium-font-size=” av-small-font-size=” av-mini-font-size=” icon_size=” av-desktop-font-size-1=” av-medium-font-size-1=” av-small-font-size-1=” av-mini-font-size-1=” color=” custom_font=” subheading_color=” seperator_color=” icon_color=” margin=” margin_sync=’true’ av-desktop-margin=” av-desktop-margin_sync=’true’ av-medium-margin=” av-medium-margin_sync=’true’ av-small-margin=” av-small-margin_sync=’true’ av-mini-margin=” av-mini-margin_sync=’true’ headline_padding=” headline_padding_sync=’true’ av-desktop-headline_padding=” av-desktop-headline_padding_sync=’true’ av-medium-headline_padding=” av-medium-headline_padding_sync=’true’ av-small-headline_padding=” av-small-headline_padding_sync=’true’ av-mini-headline_padding=” av-mini-headline_padding_sync=’true’ padding=’10’ av-desktop-padding=” av-medium-padding=” av-small-padding=” av-mini-padding=” icon_padding=’10’ av-desktop-icon_padding=” av-medium-icon_padding=” av-small-icon_padding=” av-mini-icon_padding=” link=” link_dynamic=” link_target=” title_attr=” id=” custom_class=’drb-post-title’ template_class=” element_template=” one_element_template=” av_uid=’av-km6bl8f5′ sc_version=’1.0′ admin_preview_bg=”]
Largest recall campaign in the medical technology industry
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Due to health risks – recall of CPAP and ventilators
In June 2021, an extensive recall of Philips and Löwenstein brand CPAP and ventilation devices was launched, which extended into 2022. The recall affected millions of devices worldwide and was one of the largest campaigns of its kind in the medical technology industry. Patients with sleep apnoea and those who were dependent on ventilator support were particularly affected
This was triggered by the discovery that the polyester-based sound-absorbing foam (PE-PUR) used in the devices could break down into particles and be inhaled or swallowed by patients. There was also the possibility that the foam was releasing certain chemicals.
The potential health risks associated with the disintegration of the PE-PUR foam and the release of chemicals were varied and potentially serious. The risks identified included:
- Irritation and inflammation in the respiratory tract caused by inhaled foam particles
- Headaches, nausea and vomiting due to particle exposure or chemical exposure
- Hypersensitivity and allergic reactions to the chemicals released
- Toxic effects from the chemicals and particles in the body
- Of particular concern: the possible carcinogenic potential of the released substances
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Media reports
The large-scale recall campaign was reported in numerous media outlets:
Death on ventilation – Medical devices for sleep apnoea
The devices are intended to help people who stop breathing during sleep. They increase the risk of death in some patients.
https://taz.de/Medizingeraete-bei-Schlafapnoe/!5202341/
Replacement of Philips respirators costs billions – Largest recall of medical devices
It is the largest recall of medical products: Millions of Philips respirators have to be replaced due to health hazards. But the process is slow and expensive.
https://www.tagesschau.de/wirtschaft/unternehmen/philips-beatmungsgeraete-rueckruf-100.html
US FDA classifies ResMed ventilator recall as particularly serious
The U.S. Food and Drug Administration (FDA) on Thursday classified the recall of certain respiratory masks manufactured by ResMed as particularly serious because their use can lead to serious injury or death.
https://de.marketscreener.com/kurs/aktie/RESMED-INC-14259/news/US-FDA-stuft-Ruckruf-von-Beatmungsgeraten-von-ResMed-als-besonders-schwerwiegend-ein-45727097/
Defective Philips ventilators: 124 deaths
A ventilator should actually alleviate health problems. However, in the case of home ventilators from Philips, these are now alleged to have caused serious illnesses themselves. An affected Viennese has filed a lawsuit.
https://www.puls24.at/news/chronik/defekte-philips-beatmungsgeraete-124-todesfaelle/269763
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Luxembourg: Recall of CPAP and ventilators of the Philipps and Löwenstein brands
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More about CPAP
CPAP – Echte Hilfe oder ewige Krückentherapie?
Gefährliche Beatmungsgeräte – Größter Medizinprodukt Rückruf und Endstation Schlafapnoe-Therapie
Wegen erheblicher Sicherheitsrisiken: Rückruf von CPAP- und Beatmungsgeräten
Schlafapnoe. Krücken gegen Symptome und Ursachen bleiben. Vorsicht mit Atem-Masken – Es geht besser!
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Further scientific information
CPAP erhöht das Sterberisiko.
InFo Neurologie 17, 26 (2015). https://doi.org/10.1007/s15005-015-1527-1
Association of Positive Airway Pressure With Cardiovascular Events and Death in Adults With Sleep Apnea
A Systematic Review and Meta-analysis
JAMA. 2017;318(2):156-166. doi:10.1001/jama.2017.7967
Does Obstructive Sleep Apnea Treatment Reduce Cardiovascular Risk?
It Is Far Too Soon to Say
JAMA. 2017;318(2):128-130. doi:10.1001/jama.2017.7966
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