The United States Food and Drug Administration has issued a class 1 for Mindray A3 and A5 Anesthesia Delivery System. The move was taken by the agency after discovering the fact that the device may have a gasket leak that may led to an interruption of or inadequate patient anesthesia and ventilation, temporary or permanent patient injury, or death. The gasket leak could also cause injury to bystanders and operating room personnel due to exposure from leaking anesthesia gases. The potentially affected devices were manufactured from May 2011 through March 2012 and distributed across the  United States.

The company has also issued some recommendations for medical professionals and practioners in which it has appealed to the facilities that they should consider having backup equipment to maintain patient ventilation in the event of device failure due to this issue. Meanwhile, the company is making all arrangements to fix the issue by replacing canister gaskets on affected devices. According to the company, as of November 14, 2012, approximately 70% of units affected by this action were corrected.

Medical facilities, healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the ‘s MedWatch Safety Information and Adverse Event Reporting Program: Complete and submit the report Online: MedWatch/report.htm. Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

What is Anesthesia?

Anesthesia is considered as the practice of administering drug and medicines either by injection or by inhalation (breathing in) that produce a state of unconsciousness that eliminates all sensations including the feeling of pain (analgesia) and other unpleasant sensations, which allows medical and surgical procedures to be undertaken without causing undue distress or discomfort.

Types of anesthetic given

  • Procedural sedation
  • Conscious sedation
  • Analgesia
  • Regional anesthesia

What is Class I Recall?

Class 1 recalls are issued to drugs and medical devices for having some serious and dangerous defects that could cause some serious health problems to people even death. Some of the examples where the federal agency could issue a class 1 recall include food found to contain botulinal toxin, food with undeclared allergens, a label mix-up on a life saving drug, or a defective artificial heart valve.