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 or observances which occurred during the functional testing of the unit.However, given the unit is past due for calibration, preventative maintenance is recommended, as well as changing the gas adapter as the sinter filter is dirty.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.
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