Device product
Philips Respironics E30 with Humidifier, Continuous Ventilator, Minimum Ventilatory Support, Facility Use; Product Numbers DSX9999H11, INX9999H19, RINX9999H19 The Philips Respironics E30 ventilator is intended to provide invasive and non-invasive ventilatory support for individuals with Respiratory Insufficiency. It is specifically for the care of adult and pediatric patients >7 years of age and >18kgs.
Z-1972-2021
Product summary
- Event
- Event 88058
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 15,357,775 (10,307,186 in US, 5,039,748 OUS) in total
- Official record key
device-enforcement:Z-1972-2021
Official wording
Reason: The polyester-based polyurethane (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 the PE-PUR foam may off-gas certain chemicals.
Code information: All Serial Numbers Material Numbers: DSX9999H11 INX9999H19 RINX9999H19
Distribution pattern: Global distribution
Derived failure modes
-
Unknown
The polyester-based polyurethane (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 the PE-PUR foam may off-gas certain chemicals.