一級召修 Respironics V60 Ventilators

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＊＊＊ 衛署醫器輸字第022114號 ＊＊＊  "磊仕"連續式呼吸器 台灣飛利浦股份有限公司

http://v60.respironics.com/ 

---->各位如果自己院中若有本設備，請先確認是否是名列受影響的清單中，需召修者，請跟當地Philips公司連絡

Respironics California, Inc., V60 Ventilators

Recall Class: Class I
Date Recall Initiated: June 4, 2013
Product: Respironics California, Inc., V60 Ventilators

To find Respironics Material P/N (Philips 12 Digit P/N) and Serial Numbers that are affected by this recall please see: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?ID=118739¹ 

(受影響的清單)

The recalled products were manufactured from March, 2009 through April, 2013 and distributed from November 16, 2009 through March 28, 2013.
Use: The Respironics V60 ventilator provides continuous or intermittent breathing support to pediatric patients weighing 44 pounds or greater to adult patients. This ventilator is used in hospitals or other health care facilities under the direction of qualified medical professionals such as physicians, nurses, and respiratory therapists.
Recalling Firm:Respironics California, Inc.
2271 Cosmos Court
Carlsbad, California 92011-1517
Reason for Recall: Respironics California, Inc. has initiated a recall on the V60 ventilator because of an issue with the software on the V60 Power Management Board Assembly. If a component fails on the Power Management Board Assembly, it may cause ventilator support to be lost with potentially no audible alarm from the ventilator(因電源電路板上軟體問題，若電源板上零件失效時，可能會造成呼吸器警報聲響失效). This recalled product may cause serious adverse health consequences, including death.
Public Contact: Customers may contact their local Philips Respironics representative at 1- 800- 722-9377 for any questions about this recall.
FDA District: Los Angeles District Office
FDA Comments:On June 3, 2013, Philips Healthcare sent a "MEDICAL DEVICE CORRECTION" letter to all customers who received the V60 Ventilators. The letter described the product, the problem, and the actions to be taken.
Phiilps己放2013/06/03發出通知函給各使用者，內容已有說明本次問題及可採取的因應措施
Customers were informed that the V60 ventilator may continue to be used according to its directions for use, pending the completion of the software update. In addition, customers were instructed to refer to their manual for additional information on warnings.
A Philips Field Service Engineer, Approved Service Provider, or Distributor will be contacting customers to schedule a no-cost update and replacement of the Power Management Board Assembly Software on all V60 ventilators shipped from the manufacturer prior to April 1, 2013.
當地Philips公司會與使用單位連絡並安排受影響需召修設備(2013/04/01後製造)的免費軟體升級
Customers were instructed to contact their local Philips Respironics representative at 1-800-722-9377 for any further information or support concerning this issue.

Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death. Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to MedWatch: The FDA Safety Information and Adverse Event Reporting Program² either online, by regular mail or by FAX.

FDA提醒醫儀相關資安考量問題及建議預防措施

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Cybersecurity for Medical Devices and Hospital Networks: FDA Safety Communication

Posted 06/17/2013]

AUDIENCE: Biomedical Engineering, Health Professional, Risk Manager

ISSUE: FDA is recommending that medical device manufacturers and health care facilities take steps to assure that appropriate safeguards are in place to reduce the risk of failure due to cyberattack, which could be initiated by the introduction of malware into the medical equipment or unauthorized access to configuration settings in medical devices and hospital networks.
Recently, the FDA has become aware of cybersecurity vulnerabilities and incidents that could directly impact medical devices or hospital network operations (refer to the FDA Safety Communication for examples). FDA is not aware of any patient injuries or deaths associated with these incidents nor do we have any indication that any specific devices or systems in clinical use have been purposely targeted at this time.
FDA has been working closely with other federal agencies and manufacturers to identify, communicate and mitigate vulnerabilities and incidents as they are identified. FDA also released a draft guidance on how manufacturers should address cybersecurity in their pre-market submissions, as well as guidance on how manufacturers should address cybersecurity issues related to products that use off-the-shelf software.

BACKGROUND: Many medical devices contain configurable embedded computer systems that can be vulnerable to cybersecurity breaches. In addition, as medical devices are increasingly interconnected, via the Internet, hospital networks, other medical device, and smartphones, there is an increased risk of cybersecurity breaches, which could affect how a medical device operates.

RECOMMENDATION: The FDA is recommending that you take steps to evaluate your network security and protect your hospital system. In evaluating network security, hospitals and health care facilities should consider:

• Restricting unauthorized access to the network and networked medical devices.
  限制未經授權存取院內網路和己連線網路的醫療設備。
• Making certain appropriate antivirus software and firewalls are up-to-date.
  適時更新防毒軟體及防火牆
• Monitoring network activity for unauthorized use.
  監控未經授權使用的網絡活動。
• Protecting individual network components through routine and periodic evaluation, including updating security patches and disabling all unnecessary ports and services.
  經由日常和定期評估來保護個人網路組件，包括更新安全修補，並禁用電腦上所有不必要的端口和服務。
• Contacting the specific device manufacturer if you think you may have a cybersecurity problem related to a medical device. If you are unable to determine the manufacturer or cannot contact the manufacturer, the FDA and DHS ICS-CERT may be able to assist in vulnerability reporting and resolution.
  如果你認為你可能有一個與醫療設備相關的網路安全問題請聯繫該設備製造商。 如果您無法確定製造商或無法聯繫製造商，FDA和美國國土安全部ICS-CERT可能能夠幫助脆弱性報告和決議。
• Developing and evaluating strategies to maintain critical functionality during adverse conditions.
  評估並發展相關因應策略，以能在不利條件下主要關鍵功能仍能持續運作。

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

[06/13/2013 - FDA Safety Communication - FDA]
[06/14/2014 - Cybersecurity in Medical Devices - Draft Guidance - FDA]