Dräger Medical

Aneasthesia Machines

Anaesthesia Devices COVID-19 Product Notification March 2020

Recall

Product Notification

10 Pages

Drägerwerk AG & Co... GaA, 23542 Lübeck Our reference COVID-19 – PM Anesthesiology To whom it may concern Phone +49 451 882-2665 Fax +49 451 882-72665 E-mail Moritz... hlf-Luong@draeger... m March 16th, 2020 COVID-19: Usage of Dräger anaesthesia devices for long-term ventilation Dear customers, dear health care professionals, The World Health Organization (WHO) declared COVID-19 a pandemic on March 11th, 2020 with over 118,000 cases of the coronavirus illness reported in over 110 countries worldwide... he pandemic has created a high demand for mechanical ventilation that may exceed the number of available ICU ventilators in hospitals treating patients with the disease... n the last few days many customers and health care professionals approached us, to obtain information about possibly using Dräger anaesthesia devices for long-term ventilation as an alternative ventilator when existing devices are fully utilized and there is no other ventilator option... Against these special circumstances, we believe it is our responsibility to provide some insights both (i) on the legal and regulatory perspective as well as (ii) on some known limitations of Dräger anaesthesia devices for long-term ventilation... Drägerwerk AG & Co... GaA Moislinger Allee 53-55 23558 Lübeck, Germany Postal address: 23542 Lübeck, Germany Tel +49 451 882-0 Fax +49 451 882-2080 info@draeger... m www... aeger... m VAT no... E135082211 Bank details: Commerzbank AG, Lübeck IBAN: DE95 2304 0022 0014 6795 00 Swift-Code: COBA DE FF 230 Sparkasse zu Lübeck IBAN: DE15 2305 0101 0001 0711 17 Swift-Code: NOLADE21SPL Registered office: Lübeck Commercial register: Local court Lübeck HRB 7903 HL General partner: Drägerwerk Verwaltungs AG Registered office: Lübeck Commercial register: Local court Lübeck HRB 7395 HL Chairman of the Supervisory Board for Drägerwerk AG & Co... GaA and Drägerwerk Verwaltungs AG: Stefan Lauer Executive Board: Stefan Dräger (chairman) Rainer Klug Gert-Hartwig Lescow Dr... einer Piske Anton Schrofner Page 2 / 10 I... egal and Regulatory Perspective WARNING: The following information on the legal and regulatory perspective is limited to the laws in force in the European Union (EU) as of the date of this letter and provides only general guidance... lease contact your legal counsel for guidance on your particular case... The intended use of each Dräger anaesthesia device is described in the relevant instructions for use... lthough the wording of the intended use may vary in between the devices the content is very similar: The devices are specified for a usage during surgical or diagnostic interventions under constant supervision of users... Any use of the device outside of the intended use specified in the instructions for use (e... long-term ventilation) constitutes off-label use... If a device is used off-label, the user recognizes that it is not the intended use of the device and does so in his own responsibility and at his own (liability) risk... owever, in a situation in which a patient requires long-term mechanical ventilation but cannot be ventilated due to a lack of intensive care ventilators, the benefit of being able to ventilate such a patient with a Dräger anaesthesia devices has to be weighed against the risk of the off-label usage of a Dräger anaesthesia device... his risk benefit assessment and the resulting decision has to be made by the responsible health care professional based on the circumstances of the particular case...
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File Name: Anaesthesia Devices COVID-19 Product Notification March 2020.pdf
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