H10: the biomed contacted customer service and discussed the product event [low leak co2 rebreathing, high rate alarm].The customer was advised that flow sensor assembly is faulty.Multiple good faith efforts were made to retrieve device evaluation, repair, and operational status on 09/08/2020, 09/28/2022 and 09/29/2022, however, yielded no response from the customer.It is unknown if any parts or repairs have been conducted.The complaint will be processed for closure.If additional information is received at a later date, the complaint will be reopened, and a supplemental report will be submitted.H11: e2 & e3: updated with reporter occupation.G1: updated with corrected manufacturer contact information.G2: updated report source.
|