Desflurane E_Vap.(Saf-T-Fill) used with the A9 Anesthesia System-Used to provide the vapor of an anesthetic agent with controllable concentration to an A9 anesthesia system. Part Number: Part Number115-066759-00
- Recall Initiated
- July 22, 2024
- Posted
- September 4, 2024
- Recall Number
- Z-2952-2024
- Quantity
- 96 units
- Firm Location
- Mahwah, NJ
Reason for Recall
V90 electronic vaporizer anesthetic agent output may be higher than the set amount due to a component within the vaporizer causing an incomplete seal in some cases. Should this issue occur, the A9 Anesthesia System will generate alarms associated with abnormal vaporizer output. If the anesthetic concentration is too high, the patient can inhale too much anesthetic agent; the patient may suffer from symptoms such as vertigo and drowsiness after the operation. In severe cases, the patient may suffer from neurological sequelae such as hypomnesia and inattention
Distribution
US Distribution to states of: California, Georgia, Kentucky, Mississippi, New Jersey, Puerto Rico, Texas, and West Virginia; and International (Foreign) to: Canada
Lot / Code Info
UDI-DI:06936415975760 Serial Number: AH6C25000263 AH6C25000255 AH6C27000355 AH6C27000346 AH6C27000371 AH6C25000256 AH6C25000296 AH6C25000290 AH6C27000361 AH6C25000254 AH6C25000254 AH6C25000271 AH6C25000298 AH6C25000299 AH6C25000300 AH6C25000301 AH6C25000302 AH6C27000339 AH6C27000343 AH6C27000344 AH6C27000347 AH6C27000348 AH6C27000350 AH6C27000352 AH6C27000354 AH6C27000358 AH6C27000359 AH6C27000363 AH6C27000364 AH6C27000366 AH6C27000410 AH6C27000411 AH6C28000444 AH6C28000447 AH6C28000448 AH6C28000449 AH6C28000450 AH6C28000454
Root Cause
Nonconforming Material/Component
Action Taken
Mindray issued an "URGENT Medical Device Recall" letter on July 22, 2024. Letter states reason for recall, health risk and actions to be taken: The V90 electronic vaporizer can continue to be used normally. If "Vaporizer Output Abnormal" alarm or other alarms associated with abnormal vaporizer output or high anesthetic agent alarms occur during use, take appropriate intervention per the A9 Operators manual and contact Mindray Technical Support for assistance. The intervention could be switching to another V90 electronic vaporizer, or the user can decide to switch to intravenous anesthesia. For vaporizer replacement, refer to A9 Operators manual part number H-046-017199-00, section 3.4. Vaporizer . The manual is available on the Mindray website. Mindray s Technical Support team can assist and may be reached at (877) 913-9663 (Option 1) Monday through Friday, 8:30 a.m. 5:30 p.m. ET. Please ensure that applicable clinical staff are aware of the content of this letter. Mindray will replace all affected V90 electronic vaporizers located at your facility. The V90 electronic vaporizers will be shipped directly to your facility, and a Mindray Care Team representative will contact you to schedule the installation and collect the affected V90 electronic vaporizers Contact: Director, Quality Operations and Regulatory Affairs US Agent for Shenzhen Mindray Biomedical Electronics Corp., Ltd Mindray DS USA, Inc. 201.995.8407