Safety Information for Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent, BiPAP V30 and BiPAP A30/A40 Series Medical Device Models and CPAP and Bi-Level PAP Devices
With this letter, the Federal Office for Safety in Health Care (BASG) draws attention to a possible risk from devices manufactured by Respironics, Inc. (Philips Respironics). The medical devices concerned are ventilators.
A safety notice has been issued by the manufacturer due to problems associated with the polyester-based polyurethane sound-absorbing foam. The attached safety instructions from the manufacturer contain more detailed information about the problem as well as measures to be taken by the user.
In November 2022 information was received from the manufacturer that problems have been recorded with already repaired Trilogy 100/200 ventilators. More detailed information on this can be found on the following website https://www.philips.at/a-w/about/news/archive/standard/news/2022/202211-philips-respironics-informiert.html. According to the information available to the BASG, no repaired devices have been made available in Austria to date.
Furthermore, we draw the attention of all professional users of medical devices to the legal obligation to notify the manufacturer. According to § 70 MPG, any incident that could lead to a serious health impairment or death of a patient, user or third party must be reported immediately to the Federal Office for Safety in Health Care. The reporting forms can be found online at: https://www.basg.gv.at/marktbeobachtung/meldewesen/medizinprodukte.
In addition, affected patients have the option to submit a report via informal email to email@example.com. The report should include all information known to the patient about the medical device (manufacturer, product name, other product specifications) and the incident.
For additional information, please refer to the following links:
- Information for physicians and other healthcare professionals: https://www.philips.at/healthcare/e/sleep/communications/src-update/information-for-physicians-and-providers
- Recommendation of the Austrian Society of Pneumology (ÖGP) and the Austrian Society for Sleep Medicine and Sleep Research (ÖGSM): https://www.ogp.at/stellungnahme-der-oegp-und-der-oegsm-zum-rueckruf-von-ueberdruckgeraeten-der-firma-philips/
- Recommendation of the European Respiratory Society (ERS): https://www.ersnet.org/news-and-features/news/announcement-ers-releases-statement-on-the-philips-recall-notice/
|Medical devices||Trilogy 100 |
Garbin Plus, Aeris, LifeVent
A-Series BiPAP Hybrid A30
A-Series BiPAP V30 Auto
A-Series BiPAP A40
A-Series BiPAP A30
DreamStation ST, AVAPS
C-Series S/T und AVAPS
REMstar SE Auto
|Authorised representative||Respironics Deutschland GmbH & Co. KG|
|Serial number||Alle vor dem 26. April 2021 hergestellten Geräte, alle Geräteseriennummern|
|Depth of recall||Patients|
|Further information Link||fileadmin/redakteure/05_KonsumentInnen/Medizinprodukte/2021-06-A_CPAP_FSN_-_DE_-_22-06-2021_AT.pdf|
|Company letter (pdf) Link||fileadmin/redakteure/05_KonsumentInnen/Medizinprodukte/2021-05-A_Ventilator_FSN_-_DE_-_Final_22-06-2021_AT.pdf|