GE HealthCare Software Engineer Salary User Guide
- June 16, 2024
- GE Healthcare
Table of Contents
Software Engineer Salary
User Guide
URGENT MEDICAL DEVICE CORRECTION
GE HealthCare Ref. # 34134
Date of Letter Deployment
To: Director of Respiratory
Health Care Administrator / Risk Manager
Director of Biomedical / Clinical Engineering
RE: Potential for elevated levels of Formaldehyde from EVair and EVair 03
(Jun-Air) Compressors when used with the CARESCAPE R860 or Engström
Carestation/Pro ventilators
Safety Issue
GE HealthCare has become aware of elevated levels of formaldehyde when the
EVair or EVair 03 (Jun-Air) optional compressors are used with the CARESCAPE
R860 or Engström Carestation/Pro ventilators, respectively. These elevated
results were observed in preliminary testing that was conducted at an elevated
room temperature of 40 o C (104 o F), at the lowest possible flow condition of
2 L/min (worstcase, minimum bias flow with no additional ventilation), and all
of the gas being supplied from the compressor (i.e., FiO2 of 21% / no
supplemental oxygen). GE HealthCare is continuing to evaluate the root cause
for these elevated levels of formaldehyde.
While these test conditions are not representative of typical clinical use
conditions, GE HealthCare is taking this action to further reduce the
potential for patient exposure. The amount of exposure to formaldehyde during
typical clinical use and the potential risks to health from such exposure, if
any, are currently unknown. However, in an unlikely scenario in which the
compressors are used at the conditions described above, the formaldehyde
levels may lead to adverse pulmonary affects such as the potential for
transient, reversible airway irritation or inflammation that could lead to
airway hyperresponsiveness (e.g. asthma) in neonates or infants, resulting in
additional medical intervention (e.g., bronchodilator administration,
adjustment of ventilator settings, increased duration or degree of ventilatory
support and/or oxygen support).
Compressors are optional accessories for ventilators and are only used when
wall air is not available, which is not typical in most hospital settings.
GE HealthCare has not received any reports of patient injury or adverse
effects related to potential exposure to formaldehyde from the use of the
compressors with ventilators.
Actions to be taken by Customer/ User
- GE HealthCare recommends that the EVair and EVair 03 (Jun-Air) compressors are not used to supply air to ventilators for neonatal and infant patients (0-2 years of age).
- Since the elevated levels of formaldehyde are observed when the compressors are used at higher room temperatures, GE HealthCare is also lowering the maximum room air temperature for operation of the compressors from 40° C (104° F) to 30° C (86° F).
- Please ensure all potential users in your facility are made aware of this safety notification and the recommended actions.
- Retain this document and the Addendum to the user instructions for your records. Please keep a copy of the Addendum available near the areas where the compressors are used.
- Complete and return the attached acknowledgement form to Recall_FMI 34134@ge.com.
Affected Product Details
EVair Compressor (M1230849; M1230847; GTIN: 76402146418924, 00195278366078,
07640214641892, 07640149381030, 00195278366061, 07640214641854,
07640149381023, 76402146418542) used with CARESCAPE R860 ventilator EVair 03
(Jun-Air) Compressor (1609000; 1609002; GTIN: Not Applicable) used with
Engstrom Carestation/Pro ventilators
Intended Use for EVair:
The EVair medical air compressor (EVair) is intended to be connected to a
Datex- Ohmeda Inc. critical care ventilator [CARESCAPE R860] as a supply of
compressed medical breathing air (compressed air). The ventilator must be
operated with at least one additional supply of compressed medical breathing
air or oxygen besides the EVair.
Intended Use for EVair 03 (Jun-Air):
The EVair 03 compressor is intended for use as an optional accessory to Datex-
Ohmeda critical care ventilators [Engstrom Carestation/Pro] as a breathable
compressed air supply. If the compressor is the primary air supply to the
ystem,
ensure that a compressed oxygen supply is also connected.
Product Correction
GE HealthCare has provided the attached Addendum with the updated operating
conditions (30°C (86°F) maximum room air temperature) and indications for use
specifying that the compressors are not recommended for use with neonates and
infants (0-2 years of age).
Contact Information
If you have any questions or concerns regarding this notification, please
contact GE HealthCare Service or your local Service Representative.
The FDA encourages health care providers to report any adverse events or
suspected adverse events experienced with any medical device. Health care
personnel employed by facilities that are subject to the FDA’s User Facility
Reporting Requirements should follow the reporting procedures
established by their facilities. Voluntary reports can be submitted through
MedWatch: The FDA Safety Information and Adverse Event Reporting
program online at
www.fda.gov/medwatch/report.htm.
Please be assured that maintaining a high level of safety and quality is our
highest priority. If you have any questions, please contact us per the contact
information above.
Sincerely, Laila Gurney Chief Quality & Regulatory Officer GE HealthCare Scott
Kelley
Chief Medical & Safety Officer
GE HealthCare
MEDICAL DEVICE NOTIFICATION ACKNOWLEDGEMENT RESPONSE REQUIRED
Please complete this form and return it to GE HealthCare promptly upon
receipt and no later than 30 days from receipt. This will confirm receipt and
understanding of the Medical Device Correction Notice.
Customer/Consignee
Name:………….
Street Address:………..
City/State/ZIP/Country:…………….
Customer Email Address:……………
Customer Phone Number:………………
We acknowledge receipt and understanding of the accompanying Medical Device
Notification, and that we have informed appropriate staff and have taken and
will take appropriate actions in accordance with that Notification.
Please provide the name of the individual with responsibility who completed
this form.
Indicates Mandatory Fields
Signature:………….
Printed Name:…………
Title:…………………………
*Date (DD/MM/YYYY):
Please return completed form by scanning or taking a photo of the completed
form and email to: Recall_FMI 34134@ge.com.
Addendum
This addendum is a replacement of information in the User’s Reference
Manual (URM), the pdated information for this version is identified in Bold
text. Keep this addendum with the product User’s Reference Manual. To obtain
the latest ersion of an Instruction for Use, go to: “https://customer-
doc.cloud.gehealthcare.com“. Enter the document number in the search field.
Launch the Search or use the Search By dropdown fields if the document number
is not known.
EVair User’s Reference Manual, 2066030-001
Indications for use
The EVair medical air compressor (Evair) is intended to be connected to a
Datex-Ohmeda Inc. ritical care ventilator (ventilator) as a supply of
compressed medical breathing air (compressed air). The Evair is installed in
the ventilator cart, delivers filtered, oil-free, odorless and dehumidified
compressed air and is intended to be operated by trained medical personnel.
The EVair compressor is not intended for use with neonatal or infant
patients, age 0 to 2 years.
Using the integrated backup function, the Evair can be connected inline
with an existing compressed air supply network and the ventilator. If the air
supply network fails, the Evair automatically cuts in and supplies compressed
air to the ventilator.
The ventilator must be operated with at least one additional supply of
compressed medical breathing air or oxygen besides the Evair.
Note Although this device features a high standard of quality and safety and
is built and tested according to the current standards, improper usage or
misuse can result in injuries with serious consequences.
Therefore please read this user’s reference manual carefully and keep this
documentation within reach of the device.
Environmental specifications
| Temperature| Humidity| Ambient Pressure
---|---|---|---
Operating| 10-30°C (50-86°F)| 15-95% RH, non condensing| 67-107 kPa (500-800
mmHg, 1067 mbar)| 667-
Storage| -20-65°C (-4-149°F)| 15-95% RH, non condensing| 50-107 kPa (375-800
mmHg, 1067 mbar)| 500-
Engström Carestation URM (Software 5.X M1087105, Software 6.X M1175267,
Software 7.X M1205553) and Engström Pro URM
(Software 4.X M1142527, Software 5.X M1149390, Software 6.X M1175295, Software
7.X M1205978)
EVair 03 compressor (optional)
The EVair 03 compressor is intended for use as an optional accessory to
Datex-Ohmeda critical care ventilators as a breathable compressed air supply.
The EVair compressor can act as the primary air supply or as the backup air
supply if pipeline air is connected to the compressor. If the pipeline air
pressure drops below 250 kPa (36 psi), the EVair automatically turns on to
provide an air supply to the ventilator.
The EVair 03 compressor is not intended for use with neonatal or infant
patients, age 0 to 2 years.
The compressor has no alarm functions. All alarm functions and reactions to
failure of the compressed gas supply are provided by the ventilator.
The compressor should be installed in the base of the ventilator cart. The
compressor is powered from AC mains.
If the compressor is the primary air supply to the system, ensure that a
compressed oxygen supply is also connected.
WARNING A compressor should be used if a reliable air pipeline source is
not available.
Do not block air inlet or exhaust vents. Do not place near a radiator or
heating unit.
Compressor may overheat and shut down.
The cooling air exhaust grill may become hot to the touch during use.
Do not use compressor in poorly ventilated area. Compressor will produce heat
when in use.
Do not place the compressor near a source of airborne contamination such as
cleaning products or other chemicals, vapors, odors, or exhaust gases. The
compressor uses air from its surroundings for delivery to the ventilator and
patient.|
If the compressor is the primary air supply to this system, ensure that a
compressed oxygen supply is also connected.
Environmental specifications
| Thermal| Humidity| Altitude
---|---|---|---
Operating range| 10 to 30°C (50 to 86°F)| 15 to 95% RH, noncondensing| -440 to
3565 m (800 to 500 mmHg)
Storage range| -20 to 65°C| 15 to 95% RH, non condensing| -440 to 5860 m (800
to 375 mmHg)
5955935 Rev 2023-12
References
- MedWatch: The FDA Safety Information and Adverse Event Reporting Program | FDA
- customer-doc.cloud.gehealthcare.com
- customer-doc.cloud.gehealthcare.com/
- Mandatory Reporting Requirements: Manufacturers, Importers and Device User Facilities | FDA
- MedWatch: The FDA Safety Information and Adverse Event Reporting Program | FDA
- Reporting Serious Problems to FDA | FDA
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