Trilogy EV300 ventilator: potential flow sensor malfunction from aerosol accumulation
Philips Respironics is recalling 34,146 Trilogy EV300 ventilators due to potential aerosol accumulation on the internal flow sensor, which could cause inaccurate ventilation measurements.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I classification mandates a minimum severity of 4 per the rubric. Inaccurate flow measurements in a ventilator used for pediatric through adult patients could result in serious adverse health consequences.
Plain-English summary
Philips Respironics is recalling 34,146 units of the Trilogy EV300 ventilator worldwide. The device is a portable ventilator intended for invasive and non-invasive ventilation of pediatric through adult patients weighing at least 2.5 kg, used in hospitals, homes, and non-emergency transport settings.
In certain locations, an in-line nebulizer configuration can allow aerosol deposits to accumulate on the device's internal flow sensor. This accumulation can lead to inaccurate flow measurements, potentially resulting in improper ventilation settings or patient care.
This is an FDA Class I recall affecting devices distributed worldwide. Patients and healthcare providers with affected Trilogy EV300 ventilators should contact Philips Respironics immediately for guidance on corrective measures or device replacement.
The recalled product
- Product
- Trilogy EV300. Model Numbers: DS2200X11B, IN2200X15B, BL2200X15B, BR2200X18B, CA2200X12B, DE2200X13B, GB2200X15B, ND2200X15B, ES2200X15B, FR2200X14B, FX2200X15B, EU2200X15B, IA2200X15B, IT2200X21B, KR2200X15B, TR2200X15B, EE2200X15B. Intended for invasive and non-invasive venti
- Manufacturer
- Philips Respironics, Inc.
- Category
- Medical Device — Respiratory
- Hazard
- aerosol-accumulation
- measurement-inaccuracy
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (17)
- Model Number (UDI-DI Number): DS2200X11B (606959052017)
- IN2200X15B (606959056497)
- BL2200X15B (606959058668)
- BR2200X18B (606959058583)
- CA2200X12B (606959052321)
- DE2200X13B (606959058651)
- GB2200X15B (606959058675)
- ND2200X15B (606959058620)
- ES2200X15B (606959058644)
- FR2200X14B (606959058613)
- FX2200X15B (606959061033)
- EU2200X15B (606959058682)
- IA2200X15B (606959058606)
- IT2200X21B (606959058637)
- KR2200X15B (606959058590)
- TR2200X15B (606959058798)
- EE2200X15B (606959058705). All Serial Numbers.
Distribution
Distributed nationwide across the United States.
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