GE Healthcare
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1. GE Healthcare URGENT Field Safety Notice Healthcare Systems 9900 Innovation Drive Wauwatosa WI 53226 USA December 2013 GEHC Ref 37201 To Healthcare Administrator Risk Manager Chief of Nursing Director of Biomedical Engineering RE Monitor B20 B40 V1 B30 and B40 V2 intermittent ECG filter issue GE Healthcare has recently become aware of a potential safety issue due to ECG filter settings associated with the B20 B40 V1 B30 and B40 V2 Patient Monitors Please ensure that all potential users in your facility are made aware of this safety notification and the recommended actions Safety The B20 B30 and B40 Patient Monitors set the ECG filter setting incorrectly if the monitor starts Issue with impedance respiration set in the ON position Instead of the user selected filter an additional 0 5 Hz high pass filter is used The additional 0 5 Hz high pass filter causes changes to the ECG waveform morphology and incorrect display of ST values The ST elevation measurement can be under estimated in this situation and therefore the treatment of the patient can be delayed There is no issue when the monitor starts with impedance respiration set in the OFF position Safety In order to avoid incorrect filter settings you need to save impedance respiration to be OFF as Instructions the default by following these instructions 1 Turn on the monitor 2 Ifyou have Resp displayed on the Waveform Field turn OFF Resp in Waveform Fiel2. de a correction at no charge once it is available We will contact you to arrange for this correction Contact If you have any questions regarding this notification please contact Technical Support or your Information 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 Chief Medical Officer GE Healthcare Vice President QARA GE Healthcare Systems Page 2 of 2
3. ds Monitor Setup gt Screen Setup gt Waveform Fields gt Field If you have Resp displayed on the Digit Field turn OFF Resp in Digit Fields Monitor Setup gt Screen Setup gt Digit Fields gt Field 3 Save this mode Monitor Setup gt Install Service 16 4 34 gt Save Modes 13 20 31 4 Turn off the monitor Note 1 the settings are mode related the above procedure must be repeated when the mode is changed Each time you need the impedance respiration parameter follow the below instructions before initiating patient monitoring 1 Reboot the monitor and make sure the monitor starts with impedance respiration OFF 2 Turn ON impedance respiration Note 2 for B30 don t reconnect the E PSM P W or E PSM P module when using the impedance respiration parameter only change the E PSM P W or E PSM P module when the monitor is turned OFF Affected The issues described above may occur in the following product software versions Product B20 V1 VSP A_1 13 and earlier unit SN range SGF11030001WA SGF13176741WA Page 1 of 2 B40 V1 VSP A_1 13 and earlier unit SN range SG211210001WA SG213172146WA Details B40 V2 VSP B 1 02 and earlier unit SN range SJF13010005WA SJF13180144WaA B30 L DICU08 2 1 9 and earlier unit SN range SF309380033WA SF313177120WA Product Please retain a copy of these instructions with the user manual for your B20 B30 or B40 Correction Patient Monitors GE Healthcare will provi
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