Infinity Acute Care System (lACS) Monitoring Solution; Catalog Numbers:MS20401, 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 professionals. 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.
Recall
- Recall Number
- Z-1813-2018
- Event Number
- 79871
- Firm
- Draegar Medical Systems, Inc.
- FEI Number
- 3005783425
- Product Code
- MHX
- Status
- Terminated
- Root Cause
- Under Investigation by firm
- Initiated
- March 28, 2018
- Terminated
- April 21, 2020
- Address
- 6 Tech Dr, Andover, MA, 01810-2434
Description
Infinity Acute Care System (lACS) Monitoring Solution; Catalog Numbers:MS20401, 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 professionals. 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.
Software anomaly resulting in the loss of patient settings and stored patient data.
On March 28, 2018, Drager Medical Systems Inc. mailed Urgent Medical Device Recall Notifications to affected customers. The following information was included in the notification: 1) Do not use Infinity MCable Mainstream CO2 sensors revision 16 with M540 Patient Monitor, software versions VG4.1 or lower. Previous revisions of the CO2 sensor may be used. 2) We are in process of resolving this product issue. If you choose to upgrade your system(s), your Drger service representative will schedule a service visit and upgrade your M540 patient monitor(s) once the updated software is available for distribution. 3)A Customer Reply Card will be included as a receipt from the customers that they received this information and to indicate if the customer would like the revised software update once it is available. Customer with questions regarding the notification may call (800) 437-2437 (press 1 at the prompt, then 32349) Customers with questions regarding the operation and/or servicing of the Drager Infinity Acute Care System may contact Drager Service Technical Support at (800) 437-2437 (press 4 at the prompt then 4 again).
Worldwide Distribution - USA (nationwide) and to the countries of : Angola, Argentina, Australia Austria Azerbaijan Bahrain Belgium Bolivia Brazil Brunei Dar-es-S Canada Chile China Colombia Costa Rica Czech Republic Denmark Egypt Finland France Germany Ghana 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 &Tobago Turkey Turkmenistan United Kingdom USA Utd.Arab.Emir. Vietnam
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