U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
The heart rate could be calculated from pacer pulses without indication that pacemaker detection is off in some combinations of bx50 monitors, a pdm, and cic/cscs. then the monitor does not show the pacer off message and there may not be an alarm for asystole. undetected asystole could result in irreversible changes in the patient¿s condition and delayed or missed life sustaining patient treatment.
조치
GE Healthcare sent an Urgent Medical Device Correction letter dated May 1, 2015, to all affected consignees. The letter was addressed to Healthcare Administrator / Risk Manager, Chief of Nursing, and Director of Biomedical Engineering. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. For questions contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.