1 - GE Healthcare

1 - GE Healthcare
URGENT MEDICAL DEVICE CORRECTION
June 11, 2014
To: Healthcare Administrator / Risk Manager
Chief of Nursing
Director of Biomedical Engineering
GE Healthcare
Healthcare Systems
9900 Innovation Drive
Wauwatosa, WI 53226
USA
GEHC Ref# 36101
RE: Failure of the CO2 Detector in Single-width Airway Module E-miniC and Extension Modules N-FC, N-FCREC
GE Healthcare has recently become aware of a potential safety issue due to failure of the CO2 detector associated with
Single-width Airway and Extension Modules. Please ensure that all potential users in your facility are made aware of this
safety notification and the recommended actions.
Safety
Issue
Failure of the CO2 detector in Single-width Airway and Extension modules may cause a slow continuous
decrease of measured Et-/FiCO2 values. Incorrect Et CO2/Fi CO2 value may impair clinical decision
making for both mechanically and spontaneously ventilated patients because of incorrect low CO2
values.
Safety
Instructions
Single-width Airway and Extension modules in continuous use should have a calibration check every 2
months. The calibration procedure is described in the monitor user manual instructions delivered with
your host monitor.
To determine if your Single-width Airway and Extension modules are affected by the issue above,
conduct the following calibration procedure. During this calibration procedure use calibration gas bottle
part number 755580 (5% CO2 in air) with a regulator part number 755534. No other calibration gases
should be used during this calibration procedure.
1.
2.
3.
4.
Affected
Product
Details
Before adjusting the calibration reading to match the gas bottle part #755580 calibration gas
concentration, check the CO2 reading shown in the calibration menu.
If the CO2 reading shown in the calibration menu is:
a. Above 4.4%, adjust the CO2 reading value to match the bottle concentration.
b. 4.4% or below, stop using the module and contact technical support or your local
service representative.
Reset the module by unplugging and inserting the module back to the host device. Repeat the
calibration check procedure when the host monitor allows it (typically after 5 minutes).
The CO2 reading in the calibration menu before adjustment should have remained within ± 0.2
vol% of the calibration gas (part # 755580) concentration, meaning that with 5.00% gas
concentration acceptable reading displayed on the calibration menu should be within the range
of 4.80 – 5.20%. If the CO2 reading, after successful first calibration procedure, is outside of
this specified range, stop using the module and contact technical support or your local
service representative.
Potentially affected modules were manufactured from February 10, 2012 through October 8, 2012.
Single-width Airway Modules E-miniC manufactured in this timeframe are within the serial number
range of 6818561 - 6898777 and Extension Modules N-FC and N-FCREC manufactured in this timeframe
are within the serial number range of 6799191 - 6905206. The serial number can be found on the device
plate attached to the module.
In addition, modules serviced with FRU (Field Replaceable Unit) catalog number M1013204 (miniC Unit,
N-FC(REC)) between February 2012 and May 2014 could also be affected.
The affected modules may be in use with any of the following host devices: E-miniC module with
CARESCAPE Monitors B850, B650 and B450, S/5 modular monitors, Engstrom Carestation and extension
modules N-FC(REC) with Patient Monitor B30 and S/5 FM and FML monitors.
DOC1547321-r2-EN_US
Page 1 of 2
Product
Correction
GE Healthcare will provide a correction at no charge. We will contact you to arrange for this correction.
Contact
Information
If you have any questions regarding this notice, please contact Technical Support at 1-800-558-7044 or
your local Service Representative.
Please be assured that maintaining a high level of safety and quality is our highest priority. If you have any questions, please
contact us immediately per the contact information above.
Sincerely,
James Dennison
Vice President QARA
GE Healthcare Systems
DOC1547321-r2-EN_US
Douglas M. Hansell, M.D., MPH
Chief Medical Officer
GE Healthcare
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