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

Model Number	6887900
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while the anesthesia system was used for treatment the measured peep (positive end expiratory pressure) was higher than set.There was no patient harm.Manufacturer's reference #: (b)(4).
Additional Manufacturer Narrative
The investigation of this complaint has been completed.The biomedical engineer investigated the system after the event.No faults were found, and no parts were replaced.The system was returned in clinical use without any further issues reported.The device logs were received for evaluation.Evaluation of the log shows that a successful system checkout and leakage test were performed before the event.The log shows that the treatment was started in volume control ventilation and after four hours changed to pressure support ventilation.Some clinical alarms were generated such as expiratory minute volume high and fico2 high.After another 1.5 hour the ventilation mode was changed to volume control ventilation and alarms for airway pressure high started to be generated.A change back to pressure support was performed and alarms for peep high were generated.After this were several changes between volume control ventilation, manual ventilation and pressure support ventilation performed and alarms for airway pressure high and peep high were continuously generated.The treatment was ended, and the system set to standby.The system was turned off, turned on, a successful system checkout and leakage test were performed and thereafter the treatment was started again.Based on the settings it was with same patient connected.The case was started in volume control ventilation, and within a few seconds alarms for peep high and airway pressure high were generated.The treatment was ended.The trend log shows that measured peep and airway pressure increased in the end of the treatment.The technical log has no recordings during this date, which indicate the absence of technical malfunctions in the system.The evaluation of the logs indicates that the alarms for peep high and airway pressure high was caused by an increased expiratory resistance.The root cause of the reported event has not been determined in this investigation.Our conclusion, based on the investigation on-site and the log evaluation, is that there was no technical malfunction in the system at the time of the event.
Event or Problem Description
Manufacturer's reference #: (b)(4).

• Brand Name: FLOW-E 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: 20619857
• Report Number: 8010042-2024-0001820
• Device Sequence Number: 18005368
• Product Code: BSZ
• UDI-Device Identifier: 07325710010457
• UDI-Public: (01)07325710010457(11)220711
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K191027
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2024

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: 6887900
• Device Catalogue Number: 6887900
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/08/2024
• Supplement Date Received by Manufacturer: 02/18/2025
• Initial Report FDA Received Date: 11/06/2024
• Supplement Report FDA Received Date: 02/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/11/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown