Mindray DS USA, Inc. dba Mindray North America: Sevoflurane E_Vap.(Safety Filling adapter) used with the A9 Anesthesia System-Used to provide the vapor of an anesthetic agent with controllable concent

Hazard

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

Details from the source

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 Quantity: 96 units Lot/code info: UDI-DI: 06936415975777 Serial Number: AH6A28000471 AH6A24000202 AH6A28000474 AH6A27000378 AH6A28000466 AH6A24000195 AH6A28000457 AH6A25000237 AH6A28000426 AH6A24000199 AH6A24000207

UPC codes

06936415975777

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.