The customer reported a patient who received a defibrillation shock from her pacemaker when she entered the lab.Once she excited the lab her pacemaker returned to normal function and she did not seek medical assistance.The patient ((b)(6)) was approximately 8-10 feet from emerald instrument at time of issue.Other instruments in the lab area include clinitek urine analyzer, mini-ves sed rate analyzer, architect analyzer and ge home style refrigerator.The emerald operations manual includes this warning: caution do not use mobile telephones, wireless telephones, mobile radios, or any other radio frequency (rf) transmitting devices in the same room as the instrument.
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Further investigation of the customer issue included a review of the complaint text, a search for similar complaints, review of instrument logs and a review of labeling.The emerald emissions of -6.7db and -5.7 db from 30-1000mhz are well below the limit of 47 db(uv/m) of (b)(4) standard requirement, therefore, the emerald would not cause any radio frequency interference (rfi) to other nearby electronics surrounding the cell-dyn emerald instrument if all of the other electronic devices are in compliance with the (b)(4) standard requirement.In addition, the instrument electrical and mechanical components are enclosed in metal outside covers (skin) to prevent interference from or emission of any electromagnetic interference or radioactive interference and are in compliance with emc/safety standards.No adverse trend was identified for the customer's issue.Labeling was reviewed and found to be adequate and contains the following warnings: do not place the instrument near a centrifuge, x-ray equipment, video display terminal, computer, or copier.Caution: do not use mobile telephones, wireless telephones, mobile radios, or any other radio frequency (rf) transmitting devices in the same room as the instrument.A malfunction was identified as the device failed to meet performance specifications or otherwise perform as intended at the customer site.Based on all available information and abbott diagnostics' complaint investigation no product deficiency was identified.
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