一級召修 Newport HT70,HT70 Plus

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Newport Medical Instruments, Inc., HT70 and HT70 Plus Ventilators: Class I Recall - Unit Goes Into Internal Backup Battery Sooner Than Expected
HT70  "新港"呼吸器" 台灣柯惠股份有限公司＊＊＊ 衛署醫器輸字第008004號 ＊＊＊
HT70 Plus 未引進
AUDIENCE: Risk Manager, Nursing
ISSUE: The recall is in response to customer reports of Newport Medical Instrument's HT70 Ventilator and HT70 Plus Ventilator alarming and going into internal backup battery sooner than expected, while the ventilator is being operated on Power Pac battery. Serial number range: 2096134110001 to 2292048120050(受影響機器序號), Rev. C through Rev. F These ventilators were manufactured from Nov. 1, 2009 to March 5, 2013 and distributed from Oct. 1, 2011 to Jan. 31, 2013.

回應由使用者回報狀況，當用電池操作時，機器警報後過早開始進入使用內部備份電池狀態。受影響序號機器由2096134110001 到 2292048120050 C~F版本,製造日期介於 20091101~2013.03.05 及販售日期介於 20111001~20130131

These conditions have been reported in two types of situations. In the first situation, the screen on the Newport Medical Instrument's HT70 Ventilator or HT70 Plus Ventilator may indicate that the Power Pac battery is fully charged when it is not. In the second situation, the unit may switch to backup battery power as soon as it is removed from AC power.
Use of this device on battery power may cause serious adverse health consequences, including death.
BACKGROUND: The HT70 and HT70 Plus ventilator systems are intended to provide continuous or intermittent positive pressure mechanical ventilatory support for the care of individuals who require mechanical ventilation.
Newport Medical Instruments, Inc. is a wholly-owned subsidiary of Covidien.
RECOMMENDATION: On April 4, 2013, Newport Medical Instruments sent an Urgent Medical Device Recall letter by FedEx to all its affected customers. The letter identified the product, the problem, and the action to be taken by the customer.
Anyone who has Power Pac batteries for the Newport Medical Instrument's HT70 and HT70 Plus ventilators, including distributors, health care providers, and home users, is instructed to immediately check the serial numbers of the Power Pac batteries related to their Newport HT70 and HT70 Plus ventilators. Customers whose Power Pac serial numbers fall within the above range should contact Newport Medical Instrument's Technical Support Department to request replacement batteries, which will be provided at no charge.(若機器序號包含於受影響序號中,請即連絡廠商免費更換電池包)
If customers are using the affected product, they should ensure that an alternate source of power is available nearby until this issue is resolved. Customers were also instructed to report any issues with Newport Medical Instrument's HT70 and HT70 Plus ventilators or Power Pac batteries to the Technical Support group at 1-800-451-3111, extension 500 to ensure proper device reporting procedures are followed.
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 Recall Notice, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm350438.htm

一級召修 Hospira Inc., GemStar Infusion System

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Hospira Inc., GemStar Infusion System: Recall - Lithium Battery Low Voltage

＊＊＊ 衛署醫器輸字第009822號 ＊＊＊ 赫士睿" 寶星輸液暨疼痛處理幫浦

Models 13000, 13100, 13150, 13086, 13087, 13088

AUDIENCE: Risk Manager, Biomedical Engineering, Nursing
ISSUE: Hospira notified healthcare professionals of a Class I recall of the GemStar Infusion System, Models 13000, 13100, 13150, 13086, 13087, 13088. When the GemStar Lithium battery voltage level drops below 2.4 volts, an "11/004" error is displayed and the device is rendered inoperable. This failure mode results in a delay/interruption of therapy. Additionally, infusion settings and event history logs will be erased as a result of this device malfunction.

鋰電池電壓小於2.4V時,會出現11/004錯誤碼，造成無法操作，可能會造成治療延遲或中斷。除此之外，也會造成設定值及事件記遭到清除

The severity of the clinical impact, due to the delay/interruption in therapy, is dependent upon the underlying condition of the patient and the treatment being prescribed. A delay/interruption in therapy has a worst case potential to result in a significant injury or death.
The affected units were manufactured and distributed between February 1999 and April 2013.
BACKGROUND: The GemStar Infusion System is a small, lightweight, single-channeled device designed for use in the home, hospital or anywhere electronic infusion is required. The device is intended for use in intravenous, arterial, subcutaneous, short-term epidural infusion and parenteral administration of general I.V. fluids, medications, nutritional foods and blood/blood products.
RECOMMENDATION: The customer notification letter stated that lithium batteries that are older than three (3) years should be replaced(超過3年需更換鋰電池). Contact the Hospira Advanced Knowledge Center at 1-800-241-4002, option 4, 24 hours a day/7 days a week, to determine if your battery needs to be replaced and if necessary to arrange for the return of your device to perform battery replacement. Facilities that periodically retrieve the history logs from their GemStar Infusion System should consider retrieving them more often to reduce the amount of history log information that would be lost should this failure occur.
Healthcare professionals are advised to weigh the risk/benefit to patients associated with the use of the device when administering critical therapies. Customers should consider the use of an alternative product, particularly in patients in which a delay/interruption in therapy could result in significant injury or death.
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 Press Release, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm349896.htm