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- Executive Summary - Food and Drug Administration
The gas module continuously measure the content of CO2, N2O, O2 and one of the anesthetic agents, Halothane, Isoflurane, Enflurane, Sevoflurane and Desflurane in any mixture and communicates real time and derived gas information to the Infinity monitors 2-4 K152407 Page 5 of 5
- 510 (k) Premarket Notification - Food and Drug Administration
510 (k) Premarket NotificationFDA Home Medical Devices Databases
- Class 2 Device Recall Delta - Food and Drug Administration
Class 2 Device Recall DeltaFDA Home Medical Devices Databases
- MAUDE Adverse Event Report: DRAEGER MEDICAL SYSTEMS, INC INFINITY DELTA . . .
DRAEGER MEDICAL SYSTEMS, INC INFINITY DELTA DELTA XL; PHYSIOLOGICAL MONITORING SYSTEMS Back to Search Results Device Problems Improper or Incorrect Procedure or Method (2017); Connection Problem (2900) Patient Problem Death (1802) Event Type Death Manufacturer Narrative Na Event Description A complaint was received regarding an event that occurred about 1-1 5 months ago where the involved
- MAUDE Adverse Event Report: DRAEGER MEDICAL SYSTEMS, INC INFINITY DELTA . . .
DRAEGER MEDICAL SYSTEMS, INC INFINITY DELTA; PHYSIOLOGICAL MONITORING SYSTEMS Back to Search Results Device Problems Break (1069); Detachment of Device or Device Component (2907); Device Fell (4014) Patient Problems Bone Fracture (s) (1870); Laceration (s) (1946) Event Date 01 21 2019 Event Type Injury Manufacturer Narrative A followup report will be submitted upon completion of this
- MAUDE Adverse Event Report: DRAEGER MEDICAL SYSTEMS, INC INFINITY DELTA . . .
No Type of Device Usage Reuse - - Page Last Updated: 05 31 2023
- MAUDE Adverse Event Report: DRAEGER MEDICAL SYSTEMS, INC SC7000 . . .
Number of Events Reported 1 Summary Report (Y N) N Report Source Manufacturer Source Type health professional,user faci Reporter Occupation Type of Report Initial,Followup Report Date 01 11 2018 1 Device was Involved in the Event 0 Patients were Involved in the Event: Date FDA Received 11 06 2017
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