(http://bme.freebbs.tw 醫學工程論壇同步發表)
受影響設備序號查詢 (具CAS I/II Absorbers 且為2012年10/31後交運設備)
"Spacelabs"BleaseFocus Anesthesia System "斯貝司"百利焦點麻醉機系統 衛署醫器輸字第023291號 漢佑股份有限公司
"Spacelabs" BleaseSirius Anesthesia System "斯貝司"天狼星麻醉系統 衛署醫器輸字第023172號 漢佑股份有限公司
Spacelabs Anesthesia Workstations and Service Kits: Class 1 Recall - Defect in CAS I/II Absorbers
[Posted 03/26/2013]AUDIENCE: Anesthesiology, Biomedical Engineering, Risk Managers
ISSUE: There is a defect in CAS I/II Absorbers in the Spacelabs Anesthesia Workstations and Service Kits that may cause a condition leading to an increase in the carbon dioxide concentration within the inhaled gas being delivered to the patient. This product may cause serious adverse health consequences, including death. These products were manufactured and distributed from Oct. 31, 2012 to Jan. 15, 2013.
BACKGROUND: These products are used in the hospital environment and in locations not requiring mobility of the products. They provide respiratory support to deliver oxygen, air, and nitrous oxide in a controlled manner to various patient-breathing circuits with or without the use of a mechanical ventilator, and may be used to deliver anesthetic vapor.
RECOMMENDATION: Immediately cease use of BleaseSirius and BleaseFocus Anesthesia Workstations shipped after Oct. 31, 2012. Immediately cease use of Service Kits Part Number 12200902, 050-0659-00 and 050-0901-00 and any workstation containing a CAS I/II Absorber from a Service Kit. Advise staff of this situation. Customers may call Spacelabs Medical at 1-800-522-7025 and select 2 for Technical support.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report.htm1
- Download form2 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
[03/26/2013 - Recall Notice3 - FDA]
