Infinity Acute Care System (IACS) Monitoring Solution, Catalog Numbers: MS18841, MS20401, MS20407, MS20724, MS22956, MS25510, MS25520, MS25643, MS26196, MS26372, MS31818; UDI Information: 4049098054454, 4049098054447, 4049098054409, 4049098009799, 4049098009751 Multi-parameter, physiologic patient monitoring of adult, pediatric and neonatal patients in environments where patient care is provided by trained healthcare professsionals. The lACS obtains the physiologic, multi-parameter data from the connection to the M540 monitor and optional medical devices and displays. The transfer of this data is accomplished by the Infinity network. The M540 is intended to monitor one patient at a time.
This recall has been terminated (originally issued February 21, 2018).
- Company
- Draegar Medical Systems, Inc.
- Recall Initiated
- February 21, 2018
- Terminated
- April 20, 2020
- Recall Number
- Z-1382-2018
- Quantity
- 28317 total products
- Firm Location
- Andover, MA
- Official Source
- View on FDA website ↗
Reason for Recall
The invasive pressure visual and audible alarms may not activate.
Distribution
Worldwide Distribution - USA (nationwide) and the following countries:Angola, Argentina, Australia, Austria, Azerbaijan, Bahrain, Belgium, Bolivia, Botswana, Brazil, Brunei Dar-es-S, Bulgaria, Canada, Chile, China, Columbia, Costa Rica, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Ireland, Italy, Japan, Jordan, Kenya, Kuwait, Latvia, Liechtenstein, Lithuania, Macedonia, Malaysia, Maldives, Mexico, Monaco, Mozambique, Namibia, Netherlands, New Zealand, Norway, Pakistan, Panama, Peru, Poland, Portugal, Qatar, Reunion, Russian Fed., Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Trinidad and Tobago, Turkey, Turkmenistan, United Kingdom, Utd.Arab.Emir. and Vietnam.
Lot / Code Info
Catalog Number(s): MS18841, MS20401, MS20407, MS20724, MS22956, MS25510, MS25520, MS25643, MS26196, MS26372, MS31818; UDI Information: 4049098054454, 4049098054447, 4049098054409, 4049098009799, 4049098009751
Root Cause
Software Manufacturing/Software Deployment
Action Taken
On February 21, 2018 , Drager Medical Systems Inc. mailed an Urgent Medical Device Recall Notification to affected customers, affected customers that informs the end users of the recommended connecting sequence when using the hemodynamic pod with the M540 patient monitor. A Customer Reply Card will be included as a receipt from the customers that they received and acknowledged the recommended sequence when using the hemodynamic pod with the M540 patient monitor. To avoid encountering the identified issue, the user should follow the below identified steps whenever the hemodynamic pod is plugged into the Infinity M540 patient monitor and the unit is placed in Standby. When the user is ready to monitor the patient: 1. Exit Standby mode 2. Unplug, pause for a minimum of 3 seconds and re-plug the hemodynamic pod 3. Continue per your normal procedure If there are any questions regarding the notification please call 1-800-437-2437 (press 1 at the prompt, then 32349). For questions regarding the operation and/or servicing of your Drager Infinity Acute Care System (IACS) please contact Drager Service Technical Support at 1-800-437-2437 (press 4 at the prompt and then 4 again). For further questions, please call (978) 379-8077.