一級召修 具CAS I/II Absorbers 的的Spacelabs麻醉機系統

(http://bme.freebbs.tw 醫學工程論壇同步發表)

"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

[03/26/2013] 才發佈過一次

Spacelabs Healthcare, Inc., Spacelabs Anesthesia Workstations and Service Kits: Class I Recall - Bag-to-Vent Switch in CAS I/II Absorbers May Fail

AUDIENCE: Risk Manager, Anesthesiology
ISSUE: FDA notified healthcare professionals of a Class I Recall due to a potential defect in the CAS I/II Absorber products employed in the BleaseSirius Anesthesia Workstation, BleaseFocus Anesthesia Workstation, and Service Kits Part Number 050-0659-00 and 050-0901-00. The Bag to-Vent switch in CAS I/II Absorbers may fail due to loose fastening hardware in an absorber. (The Bag to-Vent switch因固定鬆脫問題，可能會造成switch失效)

In the worst case, this would result in a large leak from the absorber circuit while operating in bag mode and could impede the ability to provide ventilation in bag mode. Operation in vent mode along with all monitoring and alarm functions will continue to operate normally.
The affected products may cause serious adverse health consequences, including death.

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: On Nov. 1, 2013, Spacelabs Healthcare sent an Urgent Medical Device Correction letter to all affected customers. Spacelabs Healthcare also sent a customer letter (translated as necessary) to all international subsidiaries and distributors of record by e-mail on Nov. 6, 2013.

(SaceLab己經發出通知信給各受影響的使用者，說明如何應因應，有使用本款設備的人，若沒收到通知信，請連絡代理商處理)
Customers were instructed to immediately advise their staff of the problem.

Customers with questions were instructed to contact Spacelabs Healthcare 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.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

Read the MedWatch safety alert, including a link to the FDA Recall Notice, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm376772.htm