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

Model Number FLOW-I C30

Device Problem Output Problem (3005)

Patient Problem Awareness during Anaesthesia (1707)

Event Type  Injury  

Event Description

It was reported that the user set the sevoflurane concentration to 8% but the reading on the screen showed either xx or zero.After quite a few minutes it was obvious that the child was still awake, so they had to move the child into another theater where the anesthesia system performed normally with the same settings and the child was put to sleep as expected.Final patient outcome: no harm.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

Our company field service engineer investigated the anesthesia system (henceforth referred to as the system) at the hospital.A check and a calibration of the gas analyzer was performed without issues.The system functioned as intended on a test lung.No parts needed to be replaced.There are no reports from the customer regarding any further issues with the system.The received logs show that a successful sco was performed prior to and after the event.The technical log contains a technical error indicating a vaporizer communication issue which may have contributed to the reported decrease in agent concentration.It can however be noticed in the logs that the decrease in agent concentration started prior to the generation of the vaporizer communication error.In addition to the low agent values, the measured volumes, pressures, and flow had variations almost throughout the entire case.After the vaporizer communication error, the user undocked the vaporizer and then re-docked it a few seconds later and the agent concentration increased slightly.A few minutes later, the user ended the case, disconnected the patient from the system and transferred the patient to another anesthesia device and continued the surgery.The evaluation of the logs can confirm that the agent delivery deviated from set agent concentration during the event but from the logs, the cause cannot be determined.As stated in the received problem description, the hospital staff connected a test lung to the system and the system worked as intended.Without being able to reproduce the reported issue during investigation at the hospital, we have not been able to determine why the agent delivery was low during several minutes during the case.

Event Description

Manufacturer's reference number: (b)(4).

• Brand Name: FLOW-I
• Type of Device: 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: 17434946
• MDR Text Key: 320201517
• Report Number: 3013876692-2023-00035
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K191027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FLOW-I C30
• Device Catalogue Number: 6677300
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/28/2023
• Distributor Facility Aware Date: 11/27/2023
• Device Age: 11 YR
• Event Location: Hospital
• Date Report to Manufacturer: 11/28/2023
• Date Manufacturer Received: 11/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/27/2011
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening