MAUDE Adverse Event Report: MAQUET CRITICAL CARE AB FLOW-I C30 ANESTHESIA SYSTEM; GAS-MACHINE, ANESTHESIA

Model Number	6888530
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the anesthesia system did not deliver any oxygen when set to 100 % o2.There was no patient harm.Manufacturer's reference #: (b)(4).
Additional Manufacturer Narrative
A correction of field # d1 brand name, # d4 version or model #, # d4 unique identifier (udi) # and # h4 manufacturer date were required.D1 ¿ brand name - previous brand name: flow-i, corrected brand name: flow-i c30 anesthesia system.D4 ¿ version or model # - previous version or model #: flow-i c30, corrected version or model #: 6888530.D4 ¿ unique identifier (udi) # - previous unique identifier (udi) #: missing, corrected unique identifier (udi) #: (b)(4).H4 ¿ manufacture date - previous manufacturing date: 03/15/2021, corrected manufacturing date: 02/26/2021.
Event or Problem Description
Manufacturer's reference #: (b)(4).
Additional Manufacturer Narrative
The investigation of the reported failure in this complaint has been completed.The system was investigated by the distributor.A complete set of device logs was received.Evaluation of the logs shows that prior to and after the event a successful system checkout was performed.The technical log has no recordings during this date which indicate the absence of technical malfunctions in the system.The event log shows that the treatment was started in manual ventilation with o2 concentration set to 100%.The apl (adjustable pressure limit) was adjusted to sp which requires effort from the patient.The log shows an inefficient co2 exchange, and decreased o2 concentrations.The measured volumes and pressures were low.No part(s) have been replaced.We have not been able to determine the true cause of the reported event.
Event or Problem Description
Manufacturer's reference #:(b)(4).

• Brand Name: FLOW-I C30 ANESTHESIA SYSTEM
• Common Device Name: GAS-MACHINE, ANESTHESIA
• Manufacturer (Section D): MAQUET CRITICAL CARE AB; roentgenvagen 2; solna
• Manufacturer (Section G): MAQUET CRITICAL CARE AB; roentgenvagen 2; solna
• Manufacturer Contact: caroline kabbabe ; roentgenvagen 2; solna
• MDR Report Key: 17926985
• Report Number: 8010042-2023-01975
• Device Sequence Number: 14195942
• Product Code: BSZ
• UDI-Device Identifier: 07325710010624
• UDI-Public: (01)07325710010624(11)210226
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• PMA/510(K) Number: K191027
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 6888530
• Device Catalogue Number: 6888530
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/14/2023
• Supplement Date Received by Manufacturer: 06/06/2024; 11/25/2024
• Initial Report FDA Received Date: 10/12/2023
• Supplement Report FDA Received Date: 06/14/2024; 11/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/26/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown