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

Model Number FLOW-I C20

Device Problem Improper Flow or Infusion (2954)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/30/2019

Event Type  malfunction  

Event Description

It was reported that during start of the case after intubation, in manual ventilation mode the anesthesia workstation failed to ventilate and to deliver gas.There was no patient harm.(b)(4).

Manufacturer Narrative

The anesthesia system was investigated on-site by our field service engineer.The nozzle units in the gas modules were replaced.The system was cleared and returned for clinical use.The nozzle units were returned for investigation and device logs were received.Simulated use testing of the returned nozzle units could not reproduce the reported failure.No alarms were generated during simulated use test and system checkout passed without deviations.Evaluation of the received device logs for the given date of event show that system checkout before the reported event was successful and that a leakage test performed after the event was successful.There is no entry in the technical log indicating a technical failure in the system.The log shows that the treatment was started in manual ventilation (man) mode.The man mode was started with the apl (adjustable pressure limit) set to sp (spontaneous).With the apl set to sp, the manual breathing bag fills slowly up to 2 cmh2o apl pressure and the patient can breathe spontaneously.After 4 minutes, the apl was increased in steps to 35 cmh2o and the o2 flush button was pressed 4 times.No alarms were generated.5 minutes after treatment start, the ventilation type was changed to automatic ventilation (auto) mode in volume control.Alarms were immediately generated for leakage, low exp.Min.Volume, high resp.Rate, check breathing circuit and high airway pressure and ventilation type was set to auto mode.Ventilation mode was thereafter switched several times between auto and man and alarms were generated all times in auto mode.After 10 minutes, the ventilation type was continued in auto mode and the issue seems to have been solved.The treatment continued for 80 minutes without further issues.The generated alarms and the many switching between man and auto mode during start of the treatment indicates that there were issues with the ventilation.However, the logs show no indication of a technical failure with the system at the given time of the event.The system functioned and generated alarms according to user settings.The root cause of the reported event cannot be determined.

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
• MDR Report Key: 8920696
• MDR Text Key: 155199109
• Report Number: 8010042-2019-00618
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• PMA/PMN Number: K160665
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/22/2021

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
• Device Operator: Health Professional
• Device Model Number: FLOW-I C20
• Device Catalogue Number: 6677200
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/30/2019
• Initial Date FDA Received: 08/22/2019
• Supplement Dates Manufacturer Received: 10/22/2021
• Supplement Dates FDA Received: 10/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1