Device product
Oxylog 3000 Plus emergency and transport ventilator
Z-2018-2023
Product summary
- Event
- Event 92443
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 300 units
- Official record key
device-enforcement:Z-2018-2023
Official wording
Reason: Draeger has become aware of instances where the device stopped working when in use when transitioning from battery to AC operation.
Code information: Catalog No. 5704811 & 5704813; UDI-DI: 04048675398295; All Serial No.
Distribution pattern: Distributed Nationwide. OUS Distribution: Afghanistan, Algeria, Andorra, Angola, Antigua/Barbados, Argentina, Australia, Austria, Azerbaijan, Bahrain, Belarus, Belgium, Bolivia, Brunei Dar-es-S, Bulgaria, Burkina-Faso, Cambodia, Canada, Cayman Islands, Chile, China, Christmas Island, Columbia, Congo, Costa Rica, Croatia, Cuba, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Equatorial Guinea, Estonia, Ethiopia, Faeroe, Finland, France, French Polynesia, French Guiana, Gabon, Georgia, Germany, Ghana, Gibraltar, Greece, Guadeloupe, Guinea, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Ivory Coast, Japan, Jordan, Kazakhstan, Kenya, Kosovo, Kuwait, Laos, Latvia, Lebanon, Libya, Liechtenstein, Lithuania, Macau, Malawi, Malaysia, Mali, Malta, Martinique, Mauritius, Mayotte, Mexico, Moldavia, Mongolia, Morocco, Myanmar, Namibia, Nepal, Netherlands, New Caledonia, New Zealand, Nigeria, North Korea, Norway, Oman, Pakistan, Panama, Pap. New Guinea, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Romania, Russian Fed., Rwanda, San Marino, Saudi Arabia, Senegal, Serbia, Singapore, Sint Maarten, Slovenia, Slovakia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Suriname, Sweden, Switzerland, Taiwan, Thailand, Trinidad/Tobago, Tunisia, Turkey, Turkmenistan, Uganda, Ukraine, United Kingdom, Uruguay, Utd. Arab. Emirates, Uzbekistan, Vietnam, Yemen, Zambia, and Zimbabwe.
Derived failure modes
-
Unknown
Draeger has become aware of instances where the device stopped working when in use when transitioning from battery to AC operation.