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 zam.zarina@philips.com

 

 A copy of FSN