一級召修 Philips Respironics, Trilogy Ventilator, Models 100, 200, and 202 - Failure to Deliver Mechanical Breaths
一級召修
廠牌:Philips Respironics,
型號:Trilogy Ventilator, Models 100, 200, and 202
狀況: Failure to Deliver Mechanical Breaths
產品批次: 2013-12-31 ~ 2014-01-30
召修原因: There is a potentially defective component on the Trilogy Ventilator power management board which could affect the function of the device.(電源電路板有潛在問題)
原文連結
Trilogy Ventilator,
Models 100,
＊＊＊ 衛署醫器輸字第020619號 ＊＊＊ 嘉杏股份有限公司
＊＊＊ 衛署醫器輸字第021289號 ＊＊＊ 嘉杏股份有限公司
Models 200 ＊＊＊ 衛署醫器輸字第021689號 ＊＊＊ 亞靖儀器有限公司
Models 202 ＊＊＊ 衛署醫器輸字第022329號 ＊＊＊ 台灣飛利浦股份有限公司
Recall Class: Class I
Date Recall Initiated: February 11, 2014
Product: Trilogy Ventilator, Models 100, 200, and 202
The affected models were manufactured and distributed from December 31, 2013 through January 30, 2014.
The serial numbers of the affected devices are located on the back of the device. See photo under Additional Links below.
Use: The Philips Respironics Trilogy Ventilator is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation.
The devices are intended to be used in home, institution/hospital, and portable applications such as wheelchairs and gurneys.
Recalling Firm:
Phillips Respironics, Inc.
1001 Murry Ridge Lane
Murrysville, Pennsylvania 15668-8517
Phillips Respironics, Inc.
1001 Murry Ridge Lane
Murrysville, Pennsylvania 15668-8517
Reason for Recall: There is a potentially defective component on the Trilogy Ventilator power management board which could affect the function of the device. If this issue is not corrected it is possible that the ventilator may fail to deliver mechanical breaths and that the alarm functionality may be reduced to indicate ventilatory failure, resulting in serious adverse health consequences or death.
During production testing Philips Respironics discovered that the affected Trilogy ventilators contain a potentially defective ferrite component on the power management board of the device.
Public Contact: Customers who have questions about this recall, require further information or support concerning this issue, may contact their local Philips Respironics representative through the Customer Care Center, 1-800-345-6443, available 24/7.
FDA District: Philadelphia District Office
FDA Comments:
On February 11, 2014 the firm initiated the recall by phoning their direct customers who are primarily wholesale dealers of home healthcare products. The firm followed up their phone calls by sending recall notification letters to their customers. On February 19, 2014, the firm issued a press release to notify consumers about the recall.
On February 11, 2014 the firm initiated the recall by phoning their direct customers who are primarily wholesale dealers of home healthcare products. The firm followed up their phone calls by sending recall notification letters to their customers. On February 19, 2014, the firm issued a press release to notify consumers about the recall.
Philips Respironics is instructing customers to remove the affected devices from service and to return them to Philips for replacement. All distributors, providers, and customers with potentially affected Trilogy devices will have their units replaced.
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 Program either online, by regular mail or by FAX.
Additional Links:
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