Jun 2021 : Respironics CPAP and Bi-Level Devices - Sound Abatement Foam Susceptibility to Degradation and Volatile Organic Compound Emission
Jun 2021 : Respironics CPAP and Bi-Level Devices - Sound Abatement Foam Susceptibility to Degradation and Volatile Organic Compound Emission
Affected Medical Device : Respironics CPAP and Bi-Level Devices
Decription : The 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.
MDA Reference Number : MDA/FCA/2021-P092
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.
Tel +6019 322 0792
Email [email protected]
