EM ALL BRASS REGULATOR

Additional Manufacturer Narrative

WHILE PERFORMING A REVIEW OF THE FILE, IT WAS DETERMINED THAT THE AFFECTED ITEM IS A DISTRIBUTED PURCHASED FINISHED GOOD (DPFG). THE ICU MEDICAL IS NOT RESPONSIBLE FOR REGULATORY REPORTING ON THIS ITEM. PLEASE DISREGARD MRN 2183161-2024-00175 AND ANY REPORTS ASSOCIATED WITH IT.

Additional Manufacturer Narrative

H3 AND H6 - EVALUATION CODES: UPDATED. DEVICE EVALUATION: ONE DEVICE WAS RETURNED FOR INVESTIGATION. NO ABNORMALITY RELATED TO THE REPORTED EVENT WAS CONFIRMED ON THE PRODUCT'S APPEARANCE. FUNCTIONAL TESTING COULD NOT DUPLICATE OR CONFIRM THE REPORTED COMPLAINT; THIS PRODUCT WORKED PROPERLY. THE ROOT CAUSE IS UNKNOWN AS THE EVENT DID NOT RECUR. THE SERVICE HISTORY REVIEW IDENTIFIED THERE WAS NO INDICATION THAT THE COMPLAINT WAS RELATED TO A SERVICE OF THE DEVICE WITHIN THE REVIEW PERIOD. NO ACTION TAKEN. A1, D4 - SERIAL NUMBER, H4 - MANUFACTURE DATE.

Description of Event or Problem

IT WAS REPORTED THAT OXYGEN CAME OUT WHEN THE GAUGE LEVEL WAS AT 0. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

Additional Manufacturer Narrative

B3. DATE OF EVENT: UNKNOWN. NO INFORMATION HAS BEEN PROVIDED TO DATE. D4. SERIAL NUMBER, UDI, AND H4. MANUFACTURE DATE ARE UNKNOWN; NO INFORMATION HAS BEEN PROVIDED TO DATE. D5. OTHER OPERATOR OF DEVICE: OPERATOR OF DEVICE IS UNKNOWN. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE.