| ||Class 1 Recall|
Philips Respironics Trilogy 100, Trilogy 200, Trilogy 202
||March 06, 2014
|Recall Event ID
Ventilator, Continuous, Facility Use - Product Code CBK
The Respironics Trilogy 100 system provides continuous or intermittent ventilator support for the care of individuals who require mechanical ventilation. Trilogy 100 is intended for pediatric through adult patients weighing at least 5 kg (11 lbs.). The device is intended to be used in home, institution/hospital, and portable applications such as wheelchairs and gurneys, and may be used for both invasive and non-invasive ventilation. It is not intended to be used as a transport ventilator. Trilogy 200 Intended Use: The Respironics Trilogy 200 system provides continuous or intermittent ventilator support for the care of individuals who require mechanical ventilation. Trilogy 200 is intended for pediatric through adult patients weighing at least 5 kg (11 lbs.). The device is intended to be used in home, institution/hospital, and portable applications such as wheelchairs and gurneys, and may be used for both invasive and non-invasive ventilation. Trilogy 202 Intended Use: The Respironics Trilogy 202 system provides continuous or intermittent ventilator support for the care of individuals who require mechanical ventilation with or without air/oxygen blending. Trilogy 202 is intended for pediatric through adult patients weighing at least 5 kg (11 lbs.). The device is intended to be used in hospitals and institutions, and for portable applications such as wheelchairs and gurneys only when in an institutional setting. It may be used for both invasive and non-invasive ventilation. It is not intended to be used as a transport ventilator.
||Model (s), Catelogue, or Code Numbers were identified as: 1040000 Trilogy 202 International, Number 1040005 Trilogy200 USA, 1054096 Trilogy 100 International,
1054260 Trilogy 100 USA, 1040004 Trilogy 02, and 1058180 Garbin. Multiple serial numbers also indicated: TV114011447; TV114011448; TV114011449
TV11401144A; TV11401144B; TV11401144C; TV11401144D; TV11401144E;
TV114011450; TV114011451; TV11401145B; TV11401145C; TV11401145D;
TV11401145F; TV114011460; TV114011461; TV114011462; TV114011464;
TV114012326; TV114012364;TV1140120A9; TV114012323; TV11401212C;
TV11401230F; TV11401235A; TV11401235C; TV114012370TV114012371
TV114012372; TV114012376; TV114012415; TV114012465; TV21401150C;
TV214011510; TV11401153D; TV11401213E; TV21401150F;TV114012165;
TV11401133A;TV114012318; TV114012433; TV11401223A; TV11401223E;
TV114012170; TV114011722; TV1140120B2;TV114012416; TV114012235;
TV114012148; TV114011550; TV1140120BB; TV114012469; TV114012459;
TV114012732;TV21401150A; TV11401130C; TV11401236D; TV114011455 ;
TV114011465; TV114012239;TV11401223B; TV11401224D;TV114011336
|Phillips Respironics, Inc.
1001 Murry Ridge Ln
Murrysville, Pennsylvania 15668-8517
|For Additional Information Contact
|Internal testing revealed a potentially defective component on the power management board that could affect the function of certain Trilogy Ventilators resulting in loss of therapy to patients.
|DESIGN: Component Design/Selection
||Philips sent an Urgent - Medical Device Recall letter on February 11, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to review the information contained in the Notice with all members of their staff who need to be aware of the contents of the communication. For further information or support concerning the issue, customers were instructed to contact Philips Respironics at 877-387-3311.
For questions regarding this recall call 724-733-0200.
|Quantity in Commerce
||Worldwide Distribution - USA (nationwide) and the countries of France, Great Britian, China, India, Italy, Korea, Kuwait, Nehterlands, and Singapore.
|Total Product Life Cycle
TPLC Device Report
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K)s with Product Code = CBK and Original Applicant = RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP
510(K)s with Product Code = CBK and Original Applicant = RESPIRONICS, INC.