Alleged failure: cib reggie, biomed dept, having issue with unit , physician had a concern the unit gave patient mild shock reaction when in use, bio tech could not find issue need another opinion, po: (b)(4).Updated information indicates that the patient heart rate dropped below 50 and they became bradycardic.The failure alleged in the complaint record was not confirmed/duplicated during the product investigation.There is no probable root cause in relation to the complaint as there were no errors during the functional testing of the unit.However, due to the unit not passing one of the initial tolerance checks prior to the functional testing, it is possible that the event details may have been attributed by the unit being out of calibration.Preventative maintenance is recommended.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.
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