Device product
Mindray DS USA Inc., Passport Series Patient Monitor intended for monitoring, displaying, reviewing, alarming, and transferring of multiple physiological parameters including ECG (3-lead, 5-lead or 12-lead selectable, arrythmia detection, ST segment analysis, and heart rate (HR), Respiration rate.
Z-2549-2016
Product summary
- Event
- Event 74704
- Status
- Terminated
- Classification
- Class II
- Quantity
- 360 units
- Official record key
device-enforcement:Z-2549-2016
Official wording
Reason: Mindray has identified a potential leakage issue with the CO2 Module's Dryline II Water Trap used with the Passport Series Patient Monitor.
Code information: 100-00080-00 - Dyrline II Water Trap, Adult 115-020919-00- CO2 Module with Accessory Kit, Adult and Pediatric Lot #1534, 1537, 1538, 1541, 1545, 1547, 1548, 1602, and 1606
Distribution pattern: Nationwide, Canada
Derived failure modes
-
Unknown
Mindray has identified a potential leakage issue with the CO2 Module's Dryline II Water Trap used with the Passport Series Patient Monitor.