Device product
Arkon Anesthesia Delivery System, Model 99999, and software version 2.61 and upgrade kit 050-9043-00 Rev G. The Spacelabs Arkon Anesthesia Workstation is intended for use in the hospital environment and operating room. It may be used for the delivery of oxygen, air and nitrous oxide in a controlled manner to various patient breathing circuits with or without the use of mechanical ventilator, and may be used for the delivery of anesthetic vapor by use of a dismountable vaporizer. The device is intended for use only by a suitably qualified physician
Z-0072-2018
Product summary
- Event
- Event 78330
- Status
- Terminated
- Classification
- Class I
- Quantity
- 110 units
- Official record key
device-enforcement:Z-0072-2018
Official wording
Reason: Arkon Anesthesia Workstation, with software version 2.61, experienced failure in mechanical ventilation, oxygen and anesthetic gas delivery, with concurrent failure of the display unit that resulted in a blank screen without audible or visible alarms.
Code information: UDI: 10841522100017
Distribution pattern: Nationwide Distribution to the states of NM, WY, FL, NC, MS, CO, CT, ME, and AL.
Derived failure modes
-
Device software or design
software version 2.61, experienced failure