1 - GE Healthcare
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1. June 11 2014 GE Healthcare URGENT MEDICAL DEVICE CORRECTION Healthcare Systems 9900 Innovation Drive Wauwatosa WI 53226 USA GEHC Ref 36101 To Healthcare Administrator Risk Manager Chief of Nursing Director of Biomedical Engineering 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 Safety Instructions Affected Product Details Failure of the CO2 detector in Single width Airway and Extension modules may cause a slow continuous decrease of measured Et FiCOz values Incorrect Et CO2 Fi CO2 value may impair clinical decision making for both mechanically and spontaneously ventilated patients because of incorrect low COz values 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. 2 in air with a regulator part number 755534 No other calibration gases should be used during this calibration procedure 1 Before adjusting the calibration reading to match the gas bottle part 755580 calibration gas concentration check the CO2 reading shown in the calibration menu 2 If the COz 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 3 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 4 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
3. 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 1of2 Product GE Healthcare will provide a correction at no charge We will contact you to arrange for this correction Correction Contact If you have any questions regarding this notice please contact Technical Support at 1 800 558 7044 or Information 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 Douglas M Hansell M D MPH Vice President QARA Chief Medical Officer GE Healthcare Systems GE Healthcare DOC1547321 r2 EN_US Page 2 of 2
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