Jun 2021 : Initial Report for 2021-05-A - Respironics Trilogy 100, Trilogy 200, V30, and A Series Device Models - Sound Abatement Foam Susceptibility to Degradation and Volatile Organic Compound Emission
Initial Report for 2021-05-A - Respironics Trilogy 100, Trilogy 200, V30, and A Series Device Models - Sound Abatement Foam Susceptibility to Degradation and Volatile Organic Compound Emission
Affected Medical Device : Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent, BiPAP V30, and BiPAP A30/A40 Series Device Models
MDA Reference Number : MDA/FCA/2021-P095
MDA Registration Number : GC35643583518
Decription : two (2) issues related to the polyester-based polyurethane (PE-PUR) sound abatement foam used in Philips Continuous and Non-Continuous Ventilators: 1) PE-PUR foam may degrade into particles which may enter the device's the air pathway and be ingested or inhaled by the user, and 2) the PE-PUR foam may off-gas certain chemicals.
Local Establishment Contact Detail :
Zam Zarina Mat Ail
Quality & Regulatory Manager
Philips Health Systems Malaysia
Philips Malaysia Sdn. Bhd. Level 9, Menara Axis, No.2, Jalan 51A/223, 46100 Petaling Jaya, Selangor Darul Ehsan. MALAYSIA.
Email : [email protected]
