MAUDE Adverse Event Report: MAQUET CRITICAL CARE AB FLOW-I C40 ANESTHESIA SYSTEM; GAS-MACHINE, ANESTHESIA

Model Number	6888540
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	01/22/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that while the anesthesia system was in use for treatment, the patient saturation decreased to 77 %.The patient was disconnected from the system and manually ventilated with an ambu bag.The patient recovered and the final patient outcome was no injury.Manufacturer's reference #: (b)(4).
Event or Problem Description
Manufacturer's reference #: (b)(4).
Additional Manufacturer Narrative
The investigation of this complaint has been completed.Our field service engineer investigated the anesthesia system.System checkout and several measurements were taken, and no fault or deviations were found.The system was returned for clinical use and no further issues have been reported.No parts were replaced.System device logs were saved and sent for evaluation.Information received from the user facility states that the medical gas technical department replaced the oxygen and medical air tubes/hoses inside the pendant on (b)(6), and since then this type of problem has not happened again.Evaluation of the received logs show that a successful system checkout was performed prior to and after the reported event.The technical log has no recordings on the date of event which indicate the absence of technical malfunctions in the system.The event log shows that treatment was started in manual ventilation with oxygen concentration set to 100 % and after 12 minutes, set to automatic ventilation in volume control and agc (automatic gas control) was started.The target fio2 was set to 40 %.After 11 minutes, one alarm for etco2 low was generated and the target fio2 was increased to max.Four minutes later, the system was set to manual ventilation for one minute and then back to automatic ventilation in volume control.Alarms for respiratory rate high and etco2 low were generated.The switching of the ventilation mode was repeated six more times and alarms for respiratory rate high, expiratory minute volume low, peep low and etco2 low were generated in automatic ventilation.These alarms together indicate a leakage.The system was set to manual ventilation during the last seven minutes until the treatment was ended.The trend log shows that around the time for the first alarm for etco2 low, the ppeak increased from about 19 cmh2o to 28 cmh2o and then further to 34 cmh2o during the following three minutes.The volume was stable and there was a gas exchange (co2 and o2) but the etco2 decreased during this time.About 30 minutes after treatment start, in connection to the switching between manual and automatic ventilation, a deviation between inspiratory and expiratory volume was logged which may indicate a leakage.The measured fio2 was according to settings during the entire treatment.There is nothing in the logs to indicate that there was a system malfunction or that the system failed to generate alarm during the treatment.Our conclusion based on our field service engineer investigation and the evaluation of the logs is that there was no system malfunction at the time of the reported event.The system detected and alarmed for the current situation when the user set alarm limits were exceeded.The root cause of the reported event has not been determined.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 c40 anesthesia system.D4 ¿ version or model # - previous version or model #: flow-i c40, corrected version or model #: 6888540.D4 ¿ unique identifier (udi) # - previous unique identifier (udi) #: missing, corrected unique identifier (udi) #: (b)(4).H4 ¿ manufacture date - previous manufacturing date: 09/08/2022, corrected manufacturing date: 08/31/2022.

• Brand Name: FLOW-I C40 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: 18630705
• Report Number: 8010042-2024-00230
• Device Sequence Number: 7930741
• Product Code: BSZ
• UDI-Device Identifier: 07325710010631
• UDI-Public: (01)07325710010631(11)220831
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: K191027
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 6888540
• Device Catalogue Number: 6888540
• 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: 01/23/2024
• Supplement Date Received by Manufacturer: 06/28/2024
• Initial Report FDA Received Date: 02/02/2024
• Supplement Report FDA Received Date: 06/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/31/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Sex: Unknown