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

Model Number FLOW-I C30

Device Problem Use of Device Problem (1670)

Patient Problem Low Oxygen Saturation (2477)

Event Date 02/09/2022

Event Type  Injury  

Event Description

It was reported that during the start of treatment, the anesthesia workstation failed to deliver oxygen when the oxygen flush button was pressed.The patient saturation decreased.The emergency ventilation was activated and the patient was ventilated manually.The patient responded with increasing saturation level.The patient was reconnected to the anesthesia workstation and the treatment continued.According to the received device logs, the anesthesia workstation was in standby at the given time of event.The anesthesia workstation require activation of the start case membrane button on the user interface to start the preset gas and ventilation settings.The final patient outcome was no injury.Manufacturer's reference #: (b)(4).

Manufacturer Narrative

Our field service engineer investigated the system on-site.No fault was found and no parts were replaced.The device logs were saved and sent for evaluation.Information received from the user facility regarding the patient saturation level at the time of the event was requested, the information received was that the patient did not suffer any hypoxic injury.The saturation level was not received.The user facility states that the system was not the primary cause of the event.A chronological order of the event was received.The system was activated into case mode and a two bag test was performed.The system was set to standby.After safety checks had been completed, rsi (rapid sequence intubation) was commenced with the system possibly still in standby.On trying to use the bag manually, there was no flow, probably due to the machine being in standby.The anesthetist started the built in emergency ventilation system.The anesthetist moved to the ambubag and tiva, and patient responded with increasing saturation levels.The anesthetic technician repeated the system checkout, the system passed the system checkout and normal fresh gas flow and ventilation was possible.The patient was connected to the system and the patient data was available.Evaluation of the received system logs confirm the course of the event.The system was in standby mode at the time of the event.There is no indications of a system malfunction in the logs.The system require activation of the start case membrane button on the user interface to start the ventilation with preset gas and ventilation settings.The user manual contains information how to start a case/treatment.Our conclusion is that there were no technical system malfunctions at the time of the event.The event was related to the user.

Event Description

Manufacturer's reference#: (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: sara soderholm roman ; roentgenvagen 2; solna
• MDR Report Key: 13720836
• MDR Text Key: 286932895
• Report Number: 8010042-2022-00449
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: K191027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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?: Yes
• Date Manufacturer Received: 06/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/18/2017
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening