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

Model Number FLOW-I C40

Device Problem Insufficient Information (3190)

Patient Problem Low Oxygen Saturation (2477)

Event Date 11/22/2020

Event Type  Injury  

Event Description

It was reported that while the anesthesia workstation was in use during a surgery, the patient did not saturate correctly.No alarms were generated.The patient had to be manually ventilated.The patient desaturation level is unknown.Manufacturer's reference #: (b)(4).

Event Description

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

Manufacturer Narrative

According to the received information from the user facility, the patient began to desaturate at about 90 minutes after the procedure had started.The anesthesia system was set to manual ventilation and the patient saturation level returned to normal.The additional information received from the user facility states that the patient's lowest saturation level during the event was 80%/75% and the saturation level returned to 100 % after the event.The anesthesia system was investigated on-site by our field service engineer.Functional and operational tests and a gas calibration were performed.No fault was found.Evaluation of the logs show that successful sco¿s were performed prior to and after the event.There are no recordings of any technical error alarms in the log that would indicate that there were any technical failure in the system.The procedure was started in manual ventilation in afgo (additional fresh gas outlet) and o2 concentration set to 100 %.After 10 minutes the ventilation type was set to automatic ventilation in prvc with o2 concentration set to 50 %.The lower etco2 alarm limit was set to 27 mmhg.About 30 minutes after the procedure start, clinical alarms for peep low, expiratory minute volume low, respiratory rate high and etco2 low were generated.The ventilation type was switched between manual and automatic ventilation a few times and was then continued automatic ventilation in prvc.The o2 concentration was increased to 98%.Alarms for etco2 low were frequently generated during 20 minutes and then ceased without any changes in settings.During the following 25 minutes, the o2 concentration was decreased in steps to 75 % and increased again to 98 %.About 90 minutes from the procedure start, several ventilation type switches between manual ventilation and automatic ventilation were performed and was after this set to manual ventilation in afgo.15 minutes later, the system was set to standby.The trend log shows that the measured inspiratory- and expiratory volumes, respiratory rate, peep and gas concentrations followed the set parameter.There was a gas exchange of both oxygen and co2.Based on the investigation on-site and the evaluation of the device logs, the conclusion is that there was no technical failure in the system at the time of the event.The cause of the reported event has not been determined.

• Brand Name: FLOW-I/E
• Type of Device: GAS-MACHINE, ANESTHESIA
• Manufacturer (Section D): MAQUET CRITICAL CARE AB; roentgenvagen 2; solna
• MDR Report Key: 11028563
• MDR Text Key: 222074621
• Report Number: 3013876692-2020-00072
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup
• Report Date: 02/03/2021

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?: Yes
• Device Operator: Health Professional
• Device Model Number: FLOW-I C40
• Device Catalogue Number: 6677400
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/03/2021
• Distributor Facility Aware Date: 02/03/2021
• Device Age: 22 MO
• Event Location: Hospital
• Date Report to Manufacturer: 02/03/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/17/2020
• Supplement Dates Manufacturer Received: 02/03/2021
• Supplement Dates FDA Received: 02/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening