for Daisy Arabella

Philips Respironics Ventilators IND 494 Dewen Liu

PART Product Functions

01

The Philips Respironics Trilogy Ventilator is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. The devices are intended to be used in home, institution/hospital, and portable applications such as wheelchairs and gurneys.

WHAT SHOULD IT DOES

PART FDA Recall 02

According to FDA…

It is possible that the ventilator may fail to deliver mechanical breaths

and that the alarm functionality may be reduced to indicate ventilatory

failure, resultingin seriousadversehealth consequencesor death.“ “

Philips Respironics says it

became aware of a problem

during production testing,

discovering that the Trilogy

ventilators contain a

potentially defective ferrite

component on the power

management board of the

device.

FDA Identified as Class I

7

Faulty alarm on the Trilogy ventilators

may fail to sound an alarm

In June 2013, 600 devices were recalled

due to a defect with the power management

system.

FDA Identified as

Class I

Problems Received

Material Choose

Design Flaw

Mechanical Error

The material may not stable or suitable, cause the problem happened

Power board error, cause people died or hurt

Bad design cause wrong

operation

PROBABLE CAUSE:

9

Re-design a better and powerful power management

board for the device which can have a large magnetic force than the old version, to provide better and stable

electric current for the device to use.

HOW

Respecfull Accomplisment Strategic Planning Honestly

Solution