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Größte Rückrufaktion in der Medizintechnik-Branche
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Wegen Gesundheitsrisiken – Rückruf von CPAP- und Beatmungsgeräten
Im Juni 2021 startete eine umfangreiche Rückrufaktion für CPAP- und Beatmungsgeräte der Marken Philips und Löwenstein, die sich bis ins Jahr 2022 hinein erstreckte. Der Rückruf betraf Millionen von Geräten weltweit und war eine der größten Aktionen dieser Art in der Medizintechnik-Branche. Besonders betroffen waren Patienten mit Schlafapnoe und solche, die auf Beatmungsunterstützung angewiesen waren
Auslöser war die Entdeckung, dass der in den Geräten verwendete schalldämpfende Schaumstoff auf Polyesterbasis (PE-PUR) in Partikel zerfallen und von Patienten eingeatmet oder verschluckt werden konnte. Zudem bestand die Möglichkeit, dass der Schaumstoff bestimmte Chemikalien freisetzte.
Die möglichen Gesundheitsrisiken, die mit dem Zerfall des PE-PUR-Schaumstoffs und der Freisetzung von Chemikalien verbunden waren, waren vielfältig und potenziell schwerwiegend. Zu den identifizierten Risiken gehörten:
- Reizungen und Entzündungen in den Atemwegen verursacht durch eingeatmete Schaumstoffpartikel
- Kopfschmerzen, Übelkeit und Erbrechen infolge Partikelexposition oder chemische Belastung
- Überempfindlichkeit und allergische Reaktionen auf die freigesetzten Chemikalien
- Toxische Wirkungen durch die Chemikalien und Partikel im Körper
- Besonders besorgniserregend: das mögliche karzinogene Potenzial der freigesetzten Substanzen
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Medienberichte
Über die groß angelegte Rückrufaktion wurde in zahlreichen Medienorganen berichtet:
Bei Beatmung Tod – Medizingeräte bei Schlafapnoe
Die Geräte sollen Menschen mit Atemstillständen während des Schlafs helfen. Sie erhöhen bei manchen PatientInnen das Sterberisiko.
https://taz.de/Medizingeraete-bei-Schlafapnoe/!5202341/
Austausch von Philips-Atemgeräten kostet Milliarden – Größter Rückruf von Medizinprodukten
Es ist der größte Rückruf von Medizinprodukten: Millionen Atemgeräte von Philips müssen wegen Gesundheitsgefahren ausgetauscht werden. Doch das geht langsam und ist teuer.
https://www.tagesschau.de/wirtschaft/unternehmen/philips-beatmungsgeraete-rueckruf-100.html
US FDA stuft Rückruf von Beatmungsgeräten von ResMed als besonders schwerwiegend ein
Die U.S. Food and Drug Administration (FDA) hat am Donnerstag den Rückruf bestimmter Beatmungsmasken des Herstellers ResMed als besonders schwerwiegend eingestuft, da deren Verwendung zu schweren Verletzungen oder zum Tod führen kann.
https://de.marketscreener.com/kurs/aktie/RESMED-INC-14259/news/US-FDA-stuft-Ruckruf-von-Beatmungsgeraten-von-ResMed-als-besonders-schwerwiegend-ein-45727097/
Defekte Philips-Beatmungsgeräte: 124 Todesfälle
Ein Beatmungsgerät sollte eigentlich gesundheitliche Probleme lindern. Doch im Falle von Heimbeatmungsgeräten der Firma Philips sollen diese nun selbst schwere Krankheiten ausgelöst haben. Ein betroffener Wiener hat Klage eingereicht.
https://www.puls24.at/news/chronik/defekte-philips-beatmungsgeraete-124-todesfaelle/269763
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Luxemburg: Rückruf von CPAP- und Beatmungsgeräten der Marken Philipps und Löwenstein
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Mehr zum Thema CPAP
Wegen erheblicher Sicherheitsrisiken: Rückruf von CPAP- und Beatmungsgeräten
CPAP – Echte Hilfe oder ewige Krückentherapie?
Gefährliche Beatmungsgeräte – Größter Medizinprodukt Rückruf und Endstation Schlafapnoe-Therapie
Schlafapnoe. Krücken gegen Symptome und Ursachen bleiben. Vorsicht mit Atem-Masken – Es geht besser!
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Weiterführende wissenschaftliche Informationen
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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